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A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer (RAMP 301)

Contact(s):

clinicaltrials@northshore.org

Sex: FEMALE

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06072781

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Inclusion Criteria:

Patients may be eligible for inclusion in the study if they meet the following criteria:
• Histologically proven LGSOC (ovarian, fallopian, peritoneal)
• Documented mutational status of KRAS by a validated tumor-tissue based diagnostic test.
• Suitable for treatment with at least one of the Investigator's Choice of Treatments:pegylated liposomal doxorubicin, paclitaxel, letrozole, anastrozole.
• Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
• Measurable disease according to RECIST v1.1.
• An Eastern Cooperative Group (ECOG) performance status ≤ 1.
• Adequate organ function.
• Adequate recovery from toxicities related to prior treatments.
• For patients with reproductive potential, a negative pregnancy test must be confirmed and agreement to use highly effective method of contraceptive.
• Willingness to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

Patients will be excluded from the study if they meet any of the following criteria:
• Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.
• Co-existing high-grade serous ovarian cancer or mixed histology.
• Prior treatment with avutometinib, defactinib, or other FAK inhibitors.
• History of prior malignancy with recurrence \<3 years from the time of enrollment.
• Major surgery within 4 weeks, minor surgery within 1 week, or palliative radiotherapy within 1 week of the first dose of study intervention.
• Symptomatic brain metastases requiring steroids or other interventions, known leptomeningeal metastases, or spinal cord compression.
• An active skin disorder that has required systemic therapy within one year of the first dose of study intervention.
• History of medically significant rhabdomyolysis.
• For subjects with prior MEK or RAF exposure, Grade 4 toxicity is deemed related to the MEK inhibitor.
• Symptomatic bowel obstruction within 3 months of the first dose of study intervention
• Concurrent ocular disorders.
• Concurrent heart disease or severe obstructive pulmonary disease.
• Active or past medical history of interstitial lung disease/pneumonitis, including drug-induced or radiation pneumonitis, pulmonary fibrosis, or adult respiratory distress syndrome (ARDS).
• Subjects with the inability to swallow oral medications.
• History of hypersensitivity to any of the active agents or ingredients of study intervention: peanut, soya, polyoxyl castor oil, etcetc.). Prior hypersensitivity to anthracyclines or anthracenediones if the use of pegylated liposomal doxorubicin (PLD) is planned.
• Pregnant or breastfeeding.
• Active, uncontrolled infection (bacterial, viral, or fungal) requiring systemic therapy.

Interventions: DRUG: avutometinib, DRUG: Defactinib, DRUG: Pegylated liposomal doxorubicin, DRUG: Paclitaxel, DRUG: Letrozole, DRUG: Anastrozole

Conditions: Low Grade Serous Ovarian Cancer

Keywords: Low Grade Serous Ovarian Cancer, KRAS, KRAS wt, KRAS mt

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Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response (TRIPLE-SWITCH)

Contact(s):

clinicaltrials@northshore.org

Sex: MALE

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06592924

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Inclusion Criteria:

* Histologically/cytologically confirmed adenocarcinoma of the prostate or participants with a PSA \>100 ng/ml (100 ug/L) and radiographic evidence of metastatic disease at diagnosis. * Metastatic disease by conventional imaging (bone scan or CT and/or MRI or PSMA-PET scan at the time of ADT initiation. * PSA of ≥ 2.0 ng/ml (2.0 ug/L) prior to commencement of ADT (this refers to patients who have histologically/cytologically confirmed adenocarcinoma of the prostate) * Patients will have recovered from any treatment-related toxicities prior to enrollment (unless ≤ grade 1, irreversible, or considered by investigator as not clinically significant). * Patients may enroll with persistent toxicities attributable to ADT, including hot flushes and fatigue, of any grade, provided these toxicities are clinically stable, not rapidly worsening, and not considered by the Investigator to pose a safety risk or impair the patient's ability to comply with study procedures. Such toxicities do not need to resolve to Grade ≤1 prior to study entry. * Receipt of ADT for mCSPC for at least 6 months and no greater than 12 months (+/- 3 weeks) at time of enrollment. * Receipt of ARPI (e.g. abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for at least 4 months (+/- 2 weeks) at time of enrollment * Patients may have had radiotherapy to prostatic bed and/or metastatic sites prior to enrollment. Potential trial participants should have recovered from radiotherapy-related toxicities prior to enrollment. * Serum testosterone \<1.7 nmol/L or 50 ng/dL. * PSA ≥ 0.2 ng/ml (0.2 ug/L) within 28 days of enrollment. * Candidate for docetaxel chemotherapy * ECOG Performance Status (PS) 0 to 2. * Adequate organ and marrow function measured within 28 days prior to enrollment. * Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate. * Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. * In accordance with CCTG policy, protocol treatment is to begin within 10 working days of participant enrollment. * If the participant and the participant's partner are of childbearing potential, they must agree to use medically accepted methods of contraception * HIV-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * Participant access to all protocol therapies must be confirmed prior to enrollment

Exclusion Criteria:

* Confirmed PSA progression, defined by an increase in PSA of 25% above the nadir since achieving castration on ADT, an absolute increase in PSA value of 2.0 ng/ml (ug/L) above nadir, and a subsequent increase in PSA of 25% further separated by 3 or more weeks. * Evidence of confirmed radiographic progression or clinical progression since start of ADT. Participants may be enrolled on the study if, in the opinion of the investigator, any new bone lesions on bone scan and CT represent flare or treatment effect. * Docetaxel criteria: * Prior treatment with taxane chemotherapy * Grade 2 or worse peripheral neuropathy * Severe hypersensitivity to drugs formulated with polysorbate 80 * Clinically significant cardiac disease including: * History of unstable angina pectoris, symptomatic pericarditis, or myocardial infarction within 6 months prior to study entry. * History of documented congestive heart failure (New York Heart Association functions classification III-IV). * Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous. * Patients with a prior or concurrent malignancy whose natural history of treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * Concurrent treatment with other anti-cancer systemic therapy other than ADT and ARPI. * Live attenuated vaccination administered within 30 days prior to enrollment/randomization. * For participants with a history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * High-grade neuroendocrine prostate cancer or small cell features (except if a participant has no histological diagnosis but a PSA \>100 ng/ml (\>100 ug/L) at diagnosis and radiographic evidence of metastatic disease)

Interventions: DRUG: Abiraterone, DRUG: Enzalutamide, DRUG: Apalutamide, DRUG: Darolutamide (BAY 1841788), DRUG: Docetaxel, DRUG: ADT

Conditions: Prostate Cancer (Adenocarcinoma)

Keywords: PR26, Castration sensitive

I'm interested

A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06136650

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Inclusion Criteria:

The main inclusion criteria include but are not limited to the following: * Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology * Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening * Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography (CT)/magnetic resonance imaging (MRI) * Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) (metastatic hormone-sensitive prostate cancer \[mHSPC\] or non-metastatic hormone-sensitive prostate cancer \[nmHSPC\]), or castration-resistant prostate cancer (CRPC) (metastatic castration-resistant prostate cancer \[mCRPC\] or non-metastatic castration-resistant prostate cancer \[nmCRPC\]), for at least 8 weeks of NHA treatment (at least 14 weeks of NHA treatment for participants with bone progression). Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than 6 cycles of docetaxel and had no radiographic disease progression while receiving docetaxel * Has had prior treatment with poly (ADP-ribose) polymerase inhibitor (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment * Has ongoing androgen deprivation therapy (ADT) with serum testosterone \<50 ng/dL (\<1.7 nM) * Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 10 days before randomization * Has adequate organ function * Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening * Participants who have adverse event (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy or ≤Grade 2 osteopenia/osteoporosis are eligible * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following: * Has presence of gastrointestinal condition * Is unable to swallow capsules/tablets * Has history of pituitary dysfunction * Has poorly controlled diabetes mellitus * Has clinically significant abnormal serum potassium or sodium level * Has any of the following at screening visit: Hypotension: systolic blood pressure (BP) \<110 mmHg, or uncontrolled hypertension: systolic BP ≥160mmHg or diastolic blood BP ≥90 mmHg, in 2 out of the 3 recordings with optimized antihypertensive therapy * Has a history of active or unstable cardio/cerebrovascular disease, including thromboembolic events * History or family history of long QTc syndrome * Has a history of seizure(s) within 6 months before providing documented informed consent (IC) or has any condition that may predispose to seizure within 12 months prior to the date of enrollment * Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place * Has received a taxane-based chemotherapy for metastatic castration-resistant prostate cancer (mCRPC) * Has not adequately recovered from major surgery or have ongoing surgical complications * Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures * Participants on an unstable dose of thyroid hormone therapy, as judged by the investigator, within 6 months before the start of the study intervention * Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids * Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention * Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention * Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat * Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated * Has known additional malignancy that is progressing or has required active treatment within the past 3 years * Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days prior to the first dose of study intervention * Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed * Active infection requiring systemic therapy * Has concurrent active Hepatitis B virus and Hepatitis C virus infection

Interventions: DRUG: Opevesostat, DRUG: Dexamethasone, DRUG: Fludrocortisone acetate, DRUG: Hydrocortisone, DRUG: Abiraterone acetate, DRUG: Prednisone acetate, DRUG: Enzalutamide

Conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC), Prostatic Neoplasms

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A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer

Contact(s):

clinicaltrials@northshore.org

Sex: MALE

Age: 18 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT07005154

Show full eligibility criteria

Inclusion Criteria:

* Participant is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features. * Participant has ECOG performance status of 0 or 1, or ECOG performance status of 2 if due to bone pain. * Participant must have an estimated life expectancy of ≥ 12 months with mHSPC or ≥ 6 months with mCRPC. * Participant is able to understand and comply with all study requirements and procedures. * Participant has been diagnosed with mCRPC or mHSPC documented by metastatic lesions on a bone scan, computed tomography (CT), magnetic resonance imaging (MRI) or prostate-specific membrane antigen positron emission tomography (PSMA-PET). * Participant is receiving ongoing ADT with a gonadotropin-releasing hormone (GnRH) analogue or has a history of bilateral orchiectomy (i.e., surgical or medical castration). Participant with mHSPC must have started castration therapy (medical or surgical) at least 14 days prior to Cycle 1 Day 1 (C1D1). Note: Participant who has not had a bilateral orchiectomy must have a plan to maintain effective GnRH analogue therapy for the duration of the study. * If the participant has mCRPC, participant has evidence of disease progression defined as 1 or more of the following criteria at study entry: * Evidence of radiographic progression of disease prior to first dose and following the most recent prostate cancer treatment, defined as progressive disease on CT/MRI per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 or on a bone scan per PCWG3. * PSA progression defined as an increase in PSA of at least 25% and ≥ 1 ng/mL above the nadir, confirmed by a second value 1 week later, and with at least 1 of the measurements within 90 days prior to screening. PSA nadir is defined as the lowest PSA during or after the most recent treatment. * If the participant has mCRPC, participant has a serum testosterone level \< 1.73 nmol/L (\< 50 ng/dL) at the Screening visit. * Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 7 months after final ASP5541 administration. * Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 7 months after final ASP5541 administration. * Male participant must not donate sperm during the treatment period and for 7 months after final ASP5541 administration. * Participant agrees not to participate in another interventional study while receiving ASP5541 in the present study. * Participant should have normal serum potassium (within the local laboratory normal range) at screening without supplementation.

Exclusion Criteria:

* Participant has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data. * Participant has known active central nervous system (CNS) metastases. Note: Participant with CNS metastases who has been treated with surgery and/or radiation therapy, who is off pharmacologic doses of glucocorticoids and who is neurologically stable is eligible. * Participant has a known additional malignancy beyond prostate cancer that requires active treatment with the exception of any of the following: * Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma of any type * Adequately treated Stage I cancer from which the participant is currently in remission and has been in remission for ≥ 2 years * Any other cancer from which the participant has been disease-free for ≥5 years * Participant has clinically significant cardiac disease, defined as any of the following: * Clinically significant cardiac arrhythmias including bradyarrhythmia which are poorly controlled. Rate-controlled atrial fibrillation is permitted. * Congenital long QT syndrome. * QT interval corrected by Fridericia's formula (QTcF) ≥450 msec at Screening. If the QT interval corrected for heart rate intervals (QTc) is prolonged in a participant with a pacemaker or bundle branch block, the participant may be enrolled in the study if confirmed by the medical monitor. * History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II or left ventricular ejection fraction measurement of \< 50% at baseline. * Cohorts 1 and 3: Participant must not have unstable angina (symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months. * Cohort 2: Participants must not have symptomatic heart failure, unstable or new-onset angina or myocardial infarction within the past 12 months. * Cohorts 1 and 3: Uncontrolled hypertension, defined as systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg that has been confirmed by 2 successive measurements despite optimal medical management. * Cohort 2: Uncontrolled hypertension, defined as systolic BP \> 140 mmHg or diastolic BP \> 90 mmHg that has been confirmed by 2 successive measurements despite optimal medical management. Participants may be receiving a maximum of 2 antihypertensives that were initiated at least 3 months prior to Cycle 1 Day 1. * Cohort 1 and 3: Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the 3 months before start of study medication (except for adequately treated catheter related venous thrombosis occurring \> 1 month before Cycle 1 Day 1). * Cohort 2: Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within the last 12 months. * Participant has any unresolved National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) (version 5.0) Grade \> 2 toxicity at the Screening visit. Note: Participant receiving ongoing hormone replacement therapy for endocrine immune-related AEs without clinical symptoms will not be excluded. * Participant has had major surgery (e.g., requiring general anesthesia) within 30 days before screening, or has not fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study. * Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to day 1. * Participant received a blood transfusion within 1 month of the first dose of study intervention. * Participant has a history of impaired pituitary or adrenal gland function (e.g., Addison's disease, Cushing's syndrome). * Participant has hemoglobin A1c (HbA1c) \> 10% (if diabetes mellitus was previously diagnosed) or HbA1c \> 8% (if diabetes mellitus was previously undiagnosed). (Excluded participant may be rescreened after referral and evidence of improved control of their condition.) * Participant has jaundice or known current active liver disease from any cause, including hepatitis A (hepatitis A virus IgM positive, but testing for hepatitis A in screening is not required), hepatitis B (hepatitis B virus surface antigen positive, confirmed by hepatitis B virus DNA), or hepatitis C (hepatitis C virus antibody positive, confirmed by hepatitis C virus RNA). * Participant has moderate or severe hepatic impairment (Child-Pugh Class B or C). * Participant has a known history of human immunodeficiency virus (HIV) infection (HIV antibody positive). * Participant has a body mass index \> 40 kg/m2. * Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria within 2 years before screening. * Participant received treatment with glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to C1D1. The use of topical, intraocular, inhalational, intranasal or intra-articular glucocorticoids is permitted. * Participant received treatment with herbal medications with known anti-cancer properties or known effects on prostate physiology within 4 weeks prior to Cycle 1 Day 1 (e.g., saw palmetto, St. John's wort, turmeric/curcumin). Participants must agree not to use herbal products during study participation. * Participant is receiving current treatment with systemic ketoconazole, abiraterone acetate (AA) or any other cytochrome P450 17A1 (CYP17) inhibitor. Participant who has received systemic ketoconazole, AA or any other CYP17 inhibitor must have discontinued these agents ≥ 4 weeks prior to the first dose of study intervention. * Participant received prior systemic treatment with a strong inducer or inhibitor of cytochrome p450 3A4 (CYP3A4) within 4 weeks of first dose of study intervention. Concomitant use of strong inducers or inhibitors of CYP3A4 are not permitted on study. * Participant requires use of biotin (i.e., vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 μg. Note: Participant who switches from a high dose to a dose of 30 μg/day or less prior to first dose of study drug is eligible for study entry. * Participant is required to use any prohibited medication on the List of Excluded Concomitant Medications. * For mCRPC participants only: Participant has been treated with any of the following for prostate cancer, during the indicated time frame prior to enrollment: * Hormonal therapy (e.g., androgen receptor blockers \[AR\] antagonists, second-generation androgen receptor pathway inhibitors \[including enzalutamide, apalutamide, darolutamide, rezvilutamide and AA\], 5-alpha reductase inhibitors, estrogens, cyproterone acetate) within 4 weeks of C1D1. Note: Participant has been treated with bicalutamide within 6 weeks prior to enrollment is not permitted. Participant has been treated with all other GnRH analogues or antagonists is permitted. * Chemotherapy within 2 weeks or 5 half-lives of C1D1 (whichever is longer) * Biologic therapy within 4 weeks of C1D1 * Immunotherapy within 4 weeks of C1D1 * Radiation therapy (includes radioligands) within 4 weeks of C1D1 * For mHSPC participants only: Participant has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer (the following exceptions are permitted): * Up to 4 months of ADT with GnRH agonists or antagonists or orchiectomy (within 3 months prior to C1D1) with or without concurrent antiandrogens. * Participant may have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to C1D1. * Up to 6 cycles of docetaxel therapy, with the last dose of docetaxel ≤ 2 months prior to C1D1. A participant who has received docetaxel should have maintained a response to docetaxel of stable disease or better, by imaging and PSA, prior to C1D1. * Up to 6 months of ADT with GnRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to C1D1 if subject was treated with docetaxel, with no radiographic evidence of disease progression or rising PSA levels prior to C1D1. * Participant has received any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to C1D1. * Participant has received ASP5541 previously. * Participant has absolute neutrophil count \< 1500/μL, platelet count \< 100000/μL or hemoglobin \< 9 g/dL (6.2 mmol/L) or international normalized ratio (INR) ≥ 1.5 (unless participant is taking oral anticoagulants in which case INR ≤ 2.0 is permitted) at Screening. Note: Participant may not have received any growth factors within 7 days or blood transfusions within 28 days prior to the hematology values obtained at Screening. * Participant has serum total bilirubin \> 1.5 x upper limit of normal (ULN) (or \> 3 x ULN for participants with documented Gilbert's disease), or serum alanine aminotransferase or aspartate aminotransferase \> 2.5 x ULN at Screening. * Participant does not have adequate renal function defined as a calculated creatinine clearance \< 30 mL/min as determined by a validated algorithm for calculating creatinine clearance. * Participant has serum albumin \< 3.0 g/dL (30 g/L) at Screening. * Participant has a known or suspected hypersensitivity to ASP5541, prednisone, or any components of the formulations used. * Participant has a gastrointestinal disorder affecting absorption.

Interventions: DRUG: ASP5541, DRUG: Prednisone, DRUG: Prednisolone, DRUG: abiraterone acetate, DRUG: Adrenocorticotropic hormone

Conditions: Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer, Metastatic Hormone Sensitive Prostate Cancer

Keywords: ASP5541, PRL-02

I'm interested

Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations (OBERON)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 40 years to 130 years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05166889

Show full eligibility criteria

Inclusion Criteria:

• Participant must be ≥ 40 years of age and capable of giving signed informed consent.
• Documented diagnosis of COPD for at least one year prior to enrolment.
• Post BD FEV1/FVC \< 0.70 and post-BD FEV1 \>20% of predicted normal value.
• Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
• Documented optimized inhaled dual or triple therapy at a stable dose for at least 3 months prior to enrolment.
• Smoking history of ≥ 10 pack-years.
• CAT total score ≥10, with each of the phlegm (sputum) and cough items with a score ≥ 2.

Exclusion Criteria:

• Clinically important pulmonary disease other than COPD.
• Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms.
• Current diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18.
• Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment that could affect safety, study findings or participants ability to complete the study.
• COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization.
• Active significant infection within the 4 weeks prior to randomization, pneumonia within 6 weeks prior to randomization, or medical condition that predisposes the participant to infection.
• Suspicion of, or confirmed, ongoing SARS-CoV-2 infection.
• Significant COVID-19 illness within the 6 months prior to enrolment.
• Unstable cardiovascular disorder.
• Diagnosis of cor pulmonale, pulmonary arterial hypertension and/or right ventricular failure.
• History of known immunodeficiency disorder, including a positive test for HIV-1 or HIV 2.
• History of positive test or treatment for hepatitis B or hepatitis C (except for cured hepatitis C)
• Evidence of active liver disease, including jaundice during screening.
• Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than one year prior to enrolment. Suspected malignancy or undefined neoplasms.
• Participants who have evidence of active TB.
• Participants that have previously received tozorakimab.
• Any clinically significant abnormal findings in physical examination, vital signs, ECG, or laboratory testing during the screening period, which in the opinion of the investigator may put the participant at risk because of their participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.
• Active vaping of any products or using smoked marijuana within the 6 months prior to randomization and during the study.

Interventions: DRUG: Tozorakimab, DRUG: Tozorakimab, DRUG: Placebo

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Keywords: Chronic Obstructive Pulmonary Disease, COPD, tozorakimab, exacerbations, ICS, LABA/LAMA

I'm interested

A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain (CPMP)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05986292

Show full eligibility criteria

Inclusion Criteria:

* have a visual analog scale (VAS) pain value \>40 and \<95 at screening and prerandomization screening. * have a history of daily pain for at least 12 weeks based on participant report or medical history * have a value of ≤30 on the pain catastrophizing scale * have a body mass index \<40 kilogram/square meter (kg/m²) (inclusive) * are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation. * are willing to discontinue all medications taken for chronic pain conditions, except rescue medication for the duration of the study

Exclusion Criteria:

* have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia * have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques) * have surgery planned during the study for any reason, related or not to the disease state under evaluation. * have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation. * have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision. * have fibromyalgia * have substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association) * have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that could be detrimental to the participant or could compromise the study. * have a positive human immunodeficiency virus (HIV) test result at screening * have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.

Interventions: DRUG: LY3016859 ISA, DRUG: LY3556050 ISA, DRUG: LY3526318 ISA, DRUG: LY3857210 ISA, DRUG: Placebo Oral, DRUG: Placebo

Conditions: Osteoarthritis, Knee, Diabetic Neuropathic Pain, Chronic Low-back Pain

I'm interested

A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis (ONWARD1)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06586112

Show full eligibility criteria

Inclusion Criteria:

• Males or females, age ≥18 years
• Diagnosis of plaque psoriasis for ≥6 months
• Plaques covering ≥10% of BSA
• PASI ≥12
• sPGA ≥3
• Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception

Exclusion Criteria:

• Nonplaque psoriasis or other inflammatory skin conditions
• immune-mediated conditions commonly associated with psoriasis (eg inflammatory bowel disease). Participants with psoriatic arthritis may participate
• Pregnant, lactating, or planning to get pregnant during the study
• Use of drugs prior to Study Day 1 that treat or may affect psoriasis: * Topical within 2 weeks * Phototherapy or any systemic treatments within 4 weeks * Any biologic agent targeted to IL-12 or IL-23 within 6 months, oral IL-12 or IL-23 or TNFα inhibitor within 2 months, or IL-17 within 4 months * Systemic immunosuppressants or immunomodulatory drugs within 4 weeks * Modulators of B cells within 6 months, or T cells within 3 months * JAK inhibitors or TYK2 inhibitors within 4 weeks * PDE4 inhibitor within 2 months * Any investigational agent, within 30 days or 5 half-lives or is currently enrolled in an investigational study
• Lack of clinical response to a TYK2, IL-12, or IL-23 targeted psoriasis treatment
• Participants with QTcF \>450 msec (males) or \>470 msec (females) at Screening
• Unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within the last 3 months
• Evidence of recent or recurrent herpes zoster or herpes simplex viral infection
• Evidence of active infection or positive test result for hepatitis B, hepatitis C, HIV or TB
• History of serious bacterial, fungal, or viral infections that led to hospitalization, or any recent serious infection requiring antibiotic treatment
• Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
• Lab abnormalities indicating significant renal, hepatic or bone marrow dysfunction
• History of any immune-mediated or inflammatory medical condition for which participants requires current systemic corticosteroids \* Stable doses of inhaled corticosteroids for treatment of asthma are allowed
• Known current malignancy or current evaluation for a potential malignancy or history of malignancy within the past 5 years prior to screening, except for adequately treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix
• Live vaccines within 4 weeks prior to Study Day 1
• Participant has planned surgery during the study period
• Any acute or chronic illness/condition or evidence of an unstable clinical condition that, in the opinion of the Investigator, will substantially increase the risk to the participant if he or she participates in the study
• History of mental illness within the last 5 years, unless receiving a fixed regimen of psychiatric medications for at least 6 months before screening or has not required or been prescribed any psychiatric medication within 12 months before screening
• Evidence of severe depressive symptoms or active suicidal ideation or behavior

Interventions: DRUG: ESK-001, DRUG: Apremilast, DRUG: Placebo

Conditions: Plaque Psoriasis

I'm interested

Methadone and Quality of Postoperative Recovery

Contact(s):

clinicaltrials@northshore.org

Sex: All

Age: 18 years to 90 years old

Phase: Phase 4

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT03168958

Show full eligibility criteria

Interventions: Drug: Methadone, Drug: Saline

Conditions: Quality of Recovery Scores

I'm interested

Effect of Methadone and Hydromorphone on the QT Interval After Anesthesia and Surgery

Contact(s):

Lucyna W Klatzco - lklatzco@northshore.org

Sex: All

Age: 18 years to 80 years old

Phase: Phase 4

Healthy Volunteers:

This study is also accepting healthy volunteers

System ID: NCT03893734

Show full eligibility criteria

Interventions: Drug: methadone, Drug: Hydromorphone

Conditions: EKG-QT Prolongation

I'm interested

A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy (ALMOND)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years to 75 years old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05707377

Show full eligibility criteria

Interventions: DRUG: Zanubrutinib, DRUG: Tacrolimus

Conditions: Primary Membranous Nephropathy

Keywords: BGB-3111, Zanubrutinib, BTKi

I'm interested

A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata (BRAVE-AA-PEDS)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 6 years to 17 years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05723198

Show full eligibility criteria

Inclusion Criteria:

* Enrollment will be fully sequential by age group, with adolescents (12 to less than 18 years old) enrolling before children (6 to less than 12 years old). * Have severe areata alopecia (AA) for at least 1 year * Diagnosis for at least 1 year * Current AA episode of at least 6 months' duration * SALT score ≥50% at screening and baseline * History of trial and failure with at least 1 available treatment (topical or other) for AA * History of psychological counseling related to AA * Current episode of severe AA of less than 8 years. * Note: Participants who have severe AA for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years.

Exclusion Criteria:

* Primarily "diffuse" type of AA (characterized by diffuse hair shedding). * Are currently experiencing other forms of alopecia including, but not limited to trichotillomania, telogen effluvium, chemotherapy-induced hair loss, or any other concomitant conditions (for example, tinea capitis, psoriasis, lupus erythematosus, or secondary syphilis) that would interfere with evaluations of the effect of study medication on AA. * Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden * Have uncontrolled arterial hypertension * Have had major surgery within 8 weeks prior to screening or will require major surgery during the study * Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking IP or interfere with the interpretation of data. * Have a positive test for hepatitis B virus (HBV) infection * Have hepatitis C virus (HCV) infection (positive for anti hepatitis C antibody with confirmed presence of HCV ribonucleic acid \[RNA\]). * Have evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.

Interventions: DRUG: Baricitinib, DRUG: Placebo

Conditions: Areata Alopecia, Alopecia, Hypotrichosis, Hair Diseases, Skin Diseases, Pathological Conditions, Anatomical

I'm interested

Anticoagulation in ICH Survivors for Stroke Prevention and Recovery (ASPIRE)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT03907046

Show full eligibility criteria

Interventions: DRUG: Apixaban, DRUG: Aspirin

Conditions: Intracerebral Hemorrhage, Atrial Fibrillation

I'm interested

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata (Up-AA)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 12 years to 63 years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06012240

Show full eligibility criteria

Interventions: DRUG: Upadacitinib, DRUG: Placebo

Conditions: Alopecia Areata

Keywords: Alopecia Areata, Upadacitinib, Rinvoq, ABT-494

I'm interested

A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years to 75 years old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06046729

Show full eligibility criteria

Interventions: DRUG: Eltrekibart, DRUG: Placebo

Conditions: Hidradenitis Suppurativa

I'm interested

A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE4

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06042920

Show full eligibility criteria

Key

Inclusion Criteria:

Inclusion Criteria for Non-Pustular Palmoplantar Psoriasis * Men and women diagnosed with stable plaque psoriasis with involvement of the palm(s)and/or sole(s) for at least 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator. * Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day 1. * Moderate-to-severe non-pustular PP psoriasis, defined as pp-PGA score of ≥ 3 on a 5-pointscale and pp-PASI ≥ 8 at both screening visit and Day 1. * A total maximum of 5 sterile pustules across both palms and soles limited only to psoriatic plaques will be allowed. * Evidence of typical plaque psoriasis outside palms and soles at both screening visit and Day 1. * Deemed by the investigator to be a candidate for phototherapy or systemic therapy. * Failed to respond to, or intolerant of ≥ 1 topical therapy. Inclusion Criteria for Genital Psoriasis * Men and women diagnosed with stable plaque psoriasis with involvement of the genital area for at least 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator. * Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day 1. * Moderate-to-severe GenPs, defined as static Physician's Global Assessment of Genitalia (s-PGA-G) score of ≥ 3 on a 6-point scale at both screening visit and Day 1. * Evidence of typical plaque psoriasis in a non-genital area at both screening visit and Day 1. * Deemed by the investigator to be a candidate for phototherapy or systemic therapy. * Failed to respond to, or intolerant of ≥ 1 topical therapy. Key

Exclusion Criteria:

Target Disease Exceptions * Has non-plaque psoriasis (for PP pustulosis, PP pustular psoriasis, isolated pustules on palms or soles with or without erythema outside psoriatic plaques, guttate, pustular, erythrodermic, and drug-induced psoriasis) at screening or Day 1. Other protocol-defined inclusion/exclusion criteria apply.

Interventions: DRUG: Deucravacitinib, DRUG: Placebo

Conditions: Palmoplantar Psoriasis, Genital Psoriasis

Keywords: Deucravacitinib, BMS-986165, SOTYKTU, Plaque psoriasis

I'm interested

Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years to 100 years old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06865651

Show full eligibility criteria

Inclusion Criteria:

• Signed informed consent must be obtained prior to participation in the study.
• Male and female participants ≥ 18 years of age at the time of signing of the informed consent forms.
• CINDU patients: Confirmed diagnosis of CINDU with a duration of ≥ 4 months (defined as onset of CINDU with supporting documentation (e.g. medical record, clinical history, photographs) and inadequate control with H1-AH at local label approved doses at the time of randomization. The response to the provocation test for each CINDU subtype is required before randomization (either during screening or prior to randomization on Day 1):
• CINDU patients: Patients should be symptomatic for their most bothersome symptom as assessed with the USDD during baseline with a NRS score of 3 or more
• CSU patients: Diagnosis of CSU (acc. to Zuberbier et al 2022c) not adequately controlled with H1-AH at approved doses alone for at least 4 weeks prior to randomization, as defined by all of the following: * UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during 7 days prior to randomization * CSU for ≥ 6 months
• Participants must be willing and able to attend the protocol defined test procedure throughout the study.

Exclusion Criteria:

• Participants who have a familial/hereditary form (e.g. familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participant's inclusion in this study.
• Diseases, other than CSU or CINDU, with urticaria or angioedema symptoms including but not limited to: * urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), * food allergies yielding urticaria symptoms when the allergen is not avoided by the dietary habits of the participant * hereditary or acquired angioedema.
• CINDU patients only: To prevent any confounding effect of CSU symptoms, the CINDU study population will consist of participants with predominant CINDU and should not have a significant share of CSU symptoms (that might make the assessment of CINDU symptoms difficult) as per the investigator's judgement.
• CSU patients only: Patients should have no relevant inducible urticaria trigger
• Any other skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism
• Known or suspected ongoing, chronic or recurrent infectious disease including but not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and/or known positivity for Human Immunodeficiency Virus (HIV) infection.
• Evidence of an ongoing Hepatitis C infection (defined by the detection at screening of Hepatitis C virus antibodies (anti-HCVAb) and hepatitis C ribonucleic acid (HCV-RNA) in participants who are positive for anti-HCVAb) and/or an ongoing Hepatitis B infection (defined by the detection of Hepatitis B virus surface antigen (HBsAg) and/or hepatitis B virus (HBV)-DNA at screening; participants who are positive for anti-hepatitis B core (HBc) antibodies but who are negative for antibodies against HBsAg and HBV-DNA can be included into the study if they agree to monitoring for HBsAg and HBV-DNA reactivation).
• Major surgery within 8 weeks prior to screening or planned surgery for the duration of the study.
• Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Screening), neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.
• Uncontrolled disease states, such as asthma, or inflammatory bowel disease, or any other disease where flares are commonly treated with oral or parenteral corticosteroids.
• History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
• History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or BUN values, or abnormal urinary constituents (e.g. proteinuria, hematuria) * Evidence of urinary obstruction, or difficulty in voiding at screening * Evidence of congenital renal abnormalities with known effect on renal function * Calculated eGFR \< 60 mL/min
• Hematology parameters at screening: * Hemoglobin: \< 10 g/dL * Platelets: \< 100,000/mm3 * Leucocytes: \< 3,000/mm3 * Neutrophils:\< 1,500/mm3
• History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at screening
• Use of other investigational drugs s within 5 half-lives or within 30 days (for small molecules) prior to Screening or until the expected pharmacodynamic (PD) effect has returned to baseline (for biologics), whichever is longer; or longer if required by local regulations
• Contraindications to or hypersensitivity to remibrutinib (or its excipients or to drugs of similar chemical classes) or other substances provided to the subjects as rescue medication to control symptoms, such as antihistamines.
• Participants taking prohibited therapies as listed in Section 6.6.2. In particular patients with pretreatment with remibrutinib or another BTK-inhibitor within 4 months prior to randomization.
• History of live or live attenuated vaccine within 6 weeks prior to randomization or requirement to receive these vaccinations at any time during the study drug treatment.
• Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d which are allowed. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited.
• Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants (NOAC)).
• History of gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion)
• Significant bleeding risk or coagulation disorders.
• Known history or evidence of ongoing alcohol or drug abuse within the last 6 months before randomization as per source records.
• Pregnant or nursing (breast feeding) women.
• Women of child-bearing potential, defined as fertile, following menarche and until becoming post-menopausal unless they are permanent sterile or they are using highly effective methods of contraception during dosing for 7 days after stopping study treatment. Highly effective contraception methods include: * Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception * Bilateral oophorectomy with or without hysterectomy, total hysterectomy or bilateral salpingectomy at least six weeks prior to the first dose of study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered to be not of child-bearing potential. * Bilateral tubal occlusion, Bilateral tubal ligation (at least six weeks prior to the first dose of study treatment) * Male partner sterilization (vasectomy) of male partner(s) of the female participant at least six months prior to screening). The vasectomized male partner should be sole partner for that participant and received medical assessment of the surgical success. * Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \< 1%), for example hormone vaginal ring or transdermal hormone contraception. The decision on the contraceptive method should be reviewed at least every 3 months to evaluate the individual need and compatibility of the method chosen. In case of use of hormonal contraception, women should have been stable on the same method for a minimum of 3 months before taking study treatment. Women are considered post-menopausal if they have no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Women are considered not of child-bearing potential if they are post-menopausal or permanently sterileor have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks prior to first dose of study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child-bearing potential. If local regulations are more stringent than the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF.

Interventions: DRUG: Remibrutinib, DRUG: Placebo

Conditions: Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)

Keywords: Remibrutinib, LOU064, Chronic urticaria, CINDU, CSU, Symptomatic dermographism, Cold urticaria, Cholinergic urticaria, Heat urticaria, Solar urticaria, Delayed pressure urticaria, Aquagenic urticaria, Contact urticaria

I'm interested

Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study (KATALYST-AV)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 50 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT07001800

Show full eligibility criteria

Interventions: DRUG: Ataciguat, DRUG: Placebo

Conditions: Moderate Aortic Valve Stenosis

Keywords: Ataciguat, sGC activator, sGC stimulator, Aortic valve stenosis, Moderate aortic valve stenosis, Calcific aortic valve stenosis, CAVS, Moderate Calcific Aortic Valve Stenosis, Aortic Stenosis (AS)

I'm interested

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 40 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT07116967

Show full eligibility criteria

Interventions: DRUG: Deucravacitinib, DRUG: Ustekinumab

Conditions: Plaque Psoriasis

Keywords: Deucravacitinib, Plaque psoriasis, Cardiovascular risk, PRAGMATYK

I'm interested

A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes (ENLIGHTEN-2)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT07282600

Show full eligibility criteria

Interventions: DRUG: Eloralintide, DRUG: Placebo

Conditions: Overweight, Obesity

Keywords: Type 2 Diabetes

I'm interested

OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 50 years to 105 years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT07136012

Show full eligibility criteria

Interventions: DRUG: Olpasiran, DRUG: Placebo

Conditions: Cardiovascular Disease

Keywords: Olpasiran, AMG 890, Coronary heart disease, CHD, Myocardial infarction, Coronary revascularization

I'm interested

Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 4 years and over

Phase: PHASE4

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06834165

Show full eligibility criteria

Interventions: DRUG: Neffy, DRUG: Adrenaline

Conditions: Allergic Reactions

I'm interested

A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT07564414

Show full eligibility criteria

Interventions: DRUG: Cagrisema, DRUG: Semaglutide

Conditions: Obesity, Type 2 Diabetes

I'm interested

A Phase 2b Study of the Effects of Camoteskimab in Adults With Moderate-to-Severe Atopic Dermatitis

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years to 65 years old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT07599813

Show full eligibility criteria

Inclusion Criteria:

• Age 18-65 inclusive, at the time of signing the informed consent.
• Chronic AD for at least 1 year based on clinically confirmed diagnosis of active AD, according to Hanfin and Rajka criteria.
• Participants with moderate-to-severe AD defined by:
• Investigator global assessment (IGA) score of ≥ 3 (on a scale of 0 to 4, in which three is moderate and four is severe) at Screening and Baseline.
• AD involvement of ≥ 10% body surface area (BSA) at Screening and Baseline.
• EASI score of ≥ 16 at Screening and at Baseline.
• Peak pruritus numerical rating scale (PP-NRS) ≥ 4 at Baseline. Note: The PP-NRS will be calculated from the 7 consecutive days immediately preceding Baseline. A minimum of 4 daily scores out of the 7 days is needed.
• Participants who are candidates for systemic therapy, defined as history of inadequate response to topical AD treatments applied for at least 28 days, or for the maximum duration recommended by the product prescribing information, or for treatment with topical AD treatments is medically inadvisable due to important side effects or safety risks.
• Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Participant provides signed informed consent

Exclusion Criteria:

• History or other evidence of severe illness or any other conditions such as psychiatric illness, severe depression or previous history of suicidal attempt in past 10 years that would render the participant, in the opinion of the Investigator, unsuitable for the study.
• Active, chronic or acute infection requiring systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the Baseline.
• Participant has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of AD or would interfere with the study assessments based on the Investigator's judgement.
• Participant has history of significant flares of AD within 4 weeks prior to screening, in the opinion of the investigator.
• Participant has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma) based on investigator judgement.
• Any clinically significant abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically significant abnormalities in the 12-lead ECG as considered by the Investigator that may interfere with the interpretation of QTc interval changes.
• Participant has severe and uncontrolled seasonal or allergic rhinitis, severe and uncontrolled asthma or any other severe and uncontrolled atopic disease as judged by the Investigator.
• Treatment of AD with medicated moisturizers available only by prescription within 2 weeks prior to the Baseline visit.
• Active human immunodeficiency virus (HIV): confirmed positive anti-HIV antibody (HIV Ab) test.
• Active hepatitis B virus (HBV): hepatitis B surface antigen (HBs Ag) positive (+) or hepatitis B core antibody (HBc Ab) positive (+) confirmed by HBV PCR positive (+).
• Active hepatitis C virus (HCV): If hepatitis C antibody positive (+), confirmed by HCV RNA test. Note: a participant with documented proof of cure from HCV may be enrolled.
• Evidence of active or latent tuberculosis.
• Receipt of live or attenuated live vaccine within 6 weeks prior to screening.
• Participant had a major surgery within 8 weeks prior to Baseline or has a major surgery planned during the study.
• Participant is known to have immune deficiency or is immunocompromised
• Diagnosed with a malignancy within 5 years of enrollment (suspected malignancy should be ruled out by blood or tissue biopsy, as applicable) with the exception of: * Completely resected basal cell or squamous cell carcinoma of the skin. * Carcinoma in situ of the cervix.
• Has had previous exposure to anti-IL-18 therapy.
• Known allergy/sensitivity to any component of IMP.
• History of use of any of these medications as follows:
• Dupilumab, tralokinumab, lebrikizumab, nemolizumab within 8 weeks prior to Baseline.
• Systemic JAKi within 4 weeks prior to Baseline.
• Any topical medicated treatment that could affect AD within 2 weeks prior to Baseline, including, but not limited to, topical corticosteroids, topical phosphodiesterase (PDE4) inhibitors, topical calcineurin inhibitors, topical JAKi, tars, antimicrobials, medical devices, and bleach baths.
• Systemic therapies (other than biologics) that could affect AD not noted above, within 4 weeks prior to Baseline, including but not limited to, retinoids, calcineurin inhibitors, methotrexate, hydroxycarbamide (hydroxyurea), azathioprine, oral/injectable corticosteroids. Note: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are also allowed.
• Treatment with any investigational biologic agent or biologic agent approved after publication of this protocol, within 12 weeks (or 5 half-lives, whichever is greater) of screening.
• Treatment with any investigational nonbiologic agent, or any investigational device or procedure, within 4 weeks (or 5 half-lives, whichever is greater) of screening.
• UV-B phototherapy (including tanning beds) or excimer laser use within 4 weeks prior to Baseline or during the study.
• PUVA treatment within 4 weeks prior to Baseline
• Sedating antihistamines, including but not limited to doxepin, hydroxyzine or diphenhydramine within 1 week prior to Baseline
• Topical products containing urea within 1 week prior to Baseline
• Systemic antibiotics within 2 weeks or topical antibiotics within 1 week prior to Baseline
• Intravenous immunoglobulin (IVIg) therapy within 12 weeks prior to Baseline.
• Female participant who is pregnant or breastfeeding or trying to conceive.
• Participant considered unlikely to adhere to treatment and/or follow the protocol in the opinion of the Investigator.

Interventions: DRUG: Camoteskimab, DRUG: Placebo

Conditions: Atopic Dermatitis, Atopic, Dermatitis, Dermatitis, Atopic, Dermatologic Disease, Eczema, Eczema Atopic Dermatitis, Eczema, Atopic

I'm interested

Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype (PERSEPHONE)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 40 years to 80 years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT07190209

Show full eligibility criteria

Interventions: DRUG: Lunsekimig, DRUG: Placebo

Conditions: Chronic Obstructive Pulmonary Disease

I'm interested

REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants (ROXI-ASPEN)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT07213778

Show full eligibility criteria

Interventions: DRUG: REGN7508, DRUG: Acetylsalicylic Acid (ASA), DRUG: Placebo

Conditions: Symptomatic Venous Thromboembolism (VTE)

Keywords: Total Knee Arthroplasty (TKA), Elective Unilateral TKA, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)

I'm interested

A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract (FORAGER-2)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT07218380

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Interventions: DRUG: Vepugratinib, OTHER: Placebo, DRUG: EV, DRUG: Pembrolizumab

Conditions: Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Neoplasm Metastasis

Keywords: FGFR3, Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma

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Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials (RIVER-AD)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 12 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05492578

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Inclusion Criteria:

* Participant must be at least 12 years of age inclusive at the time of signing the informed consent. * Participated in an amlitelimab clinical trial for moderate to severe AD and received study treatment, adequately completed the assessments required for the treatment period. * Have reached the rollover timepoint to LTS17367 at the last visit of the treatment period of their feeder study SFY17915, INT18404, EFC17599, or EFC17600 * Participants in DRI17366 must only be enrolled from 1 of the following 3 groups: * The first group: participants at Week 24 in the DRI17336 study who have not achieved an ≥ Eczema Area and Skin Severity Index (EASI)-75 and are Investigator Global Assessment (IGA) ≥ 2. * The second group: participants entering LTS17367 between Week 28 and Week 52 of the feeder study, due to loss of clinical response in the part 2 of the feeder study. Timepoints for entering LTS17367 are Weeks 28, 32, 36, 40, 44, 48 or 52. * The third group: participants at Week 24 in DRI17366 who have been re-randomized and who subsequently complete the study to Week 52, enter safety follow-up and experience worsening of their AD during safety follow-up. * Participated in DRI17366 completing the previous study safety follow up (Week 68) and wish to re-initiate treatment with amlitelimab up to one year after the last visit * Complied with the previous clinical trial protocol to the satisfaction of the investigator * Body weight must be ≥25 kg * Provided signed informed assent/or consent and able to comply with the requirements of the protocol

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply: * Developed a medical condition that would preclude participation as described in the section for permanent discontinuation of the feeder study or LTS17367 protocol * Known history of or suspected current significant immunosuppression, including history of invasive opportunistic infections or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration * History of solid organ or stem cell transplant * Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to baseline) * Participants positive for human immunodeficiency virus (HIV); participants with any of the following results at Screening (Visit 1) or at any point during the feeder study: presence of HBsAg with or without HBV DNA PCR test, or presence of anti-HBc Ab or presence of anti-HBs Ab with positive HBV DNA PCR test; positive HCVAb confirmed by positive HCV RNA PCR test * History (within last 2 years prior to baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator * Participants with active TB, latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, non-TB mycobacterial infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to screening * Participants with an indeterminate or a confirmed positive IGRA test are excluded from the study unless all of the following conditions are met:
• Have a history of prior documented completed chemoprophylaxis for latent TB infection (with a treatment regimen as per local guidelines), OR treated for active TB infection
• Have been in written form approved for participation in the present trial by a TB specialist who ruled out latent or active TB infection or other mycobacterial infection in the participant
• For whom review and approval from Sponsor have been granted are eligible * Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease * Skin co-morbidity that would adversely affect the ability to undertake AD assessments (e.g., psoriasis, tinea corporis, lupus erythematosus) as per Investigator's judgment * Any medical condition which, in the opinion of the Investigator may present an unreasonable risk to the study participant as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments * In the Investigator's opinion, medical conditions related to prior AD medications that have not healed/fully recovered for more than 2 weeks before screening visit, including, but not limited to, conjunctivitis, keratitis, eosinophilic conditions, arthralgia, herpes zoster, thrombosis The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Interventions: DRUG: Amlitelimab, DRUG: Topical corticosteroids, DRUG: Topical calcineurin inhibitors, DRUG: Oral corticosteroids

Conditions: Dermatitis Atopic

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Study of Neoadjuvant Chemotherapy Plus Trastuzumab and Pertuzumab in HER2-Negative Breast Cancer Patients With Abnormal HER2 Signaling (FB-12)

Contact(s):

clinicaltrials@northshore.org

Sex: Female

Age: 18 years and over

Phase: Phase 2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT03412643

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Inclusion Criteria:

SCREENING PRIOR TO INITIATING CHEMOTHERAPY Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy. The primary breast tumor must be palpable and measure greater than or equal 2.0 cm on physical exam. The regional lymph nodes can be cN0, cN1, or cN2a. Histological grade II or III tumor. Ipsilateral axillary lymph nodes must be evaluated by imaging (mammogram, ultrasound, and/or MRI) within 6 weeks prior to initiating chemotherapy. If suspicious or abnormal, FNA or core biopsy is recommended, also within 6 weeks prior to initiating chemotherapy. Findings of these evaluations will be used to determine the nodal status prior to initiating chemotherapy.
• Nodal status - negative: Imaging of the axilla is negative; Imaging is suspicious or abnormal but the FNA or core biopsy of the questionable node(s) on imaging is negative;
• Nodal status - positive: FNA or core biopsy of the node(s) is cytologically or histologically suspicious or positive. Imaging is suspicious or abnormal but FNA or core biopsy was not performed. Tumor specimen obtained at the time of diagnosis must have ER and progesterone receptor (PgR) analysis assessed by current ASCO/CAP Guidelines. Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors. Tumor specimen obtained at the time of diagnosis must have been determined to be HER2-negative as follows:
• Immunohistochemistry (IHC) 0-1+; or
• IHC 2+ and in situ hybridization (ISH) non-amplified with a ratio of HER2 to chromosome enumeration probe 17 (CEP17) less than 2.0, and if reported, average HER2 gene copy number less than 4 signals/cells; or
• ISH non-amplified with a ratio of HER2 to CEP17 less than 2.0, and if reported, average HER2 gene copy number less than 4 signals/cells. Blood counts performed within 6 weeks prior to initiating chemotherapy must meet the following criteria:
• absolute neutrophil count (ANC) must be greater than or equal 1200/mm3;
• platelet count must be greater than or equal 100,000/mm3; and
• hemoglobin must be greater than or equal 10 g/dL. The following criteria for evidence of adequate hepatic function performed within 6 weeks prior to initiating chemotherapy must be met:
• total bilirubin must be less than or equal to upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation greater than ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
• alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab; and
• aspartate aminotransferase (AST) must be less than or equal to 1.5 x ULN for the lab.
• Alkaline phosphatase and AST may not both be greater than the ULN. For example, if the alkaline phosphatase is greater than the ULN but less than or equal to 2.5 x ULN, the AST must be less than or equal to the ULN. If the AST is greater than the ULN but less than or equal to 1.5 x ULN, the alkaline phosphatase must be less than or equal to ULN. Note: If alanine aminotransferase (ALT) is performed instead of AST (per institution's standard practice), the ALT value must be less than or equal to 1.5 x ULN; if both were performed, the AST must be less than or equal to 1.5 x ULN. Patients with AST or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET-CT, or PET scan) performed within 6 weeks prior to initiating chemotherapy does not demonstrate metastatic disease and the requirements in next criteria are met. Patients with alkaline phosphatase that is greater than ULN but less than or equal to 2.5 x ULN or unexplained bone pain are eligible for inclusion in the study if a bone scan, PET-CT scan, or positron emission tomography (PET) scan performed within 6 weeks prior to initiating chemotherapy does not demonstrate metastatic disease. Serum creatinine performed within 6 weeks prior to initiating chemotherapy must be less than or equal to 1.5 x ULN for the lab. The left ventricular ejection fraction (LVEF) assessment by echocardiogram or multi-gated acquisition (MUGA) scan performed within 90 days prior to initiating chemotherapy must be greater than or equal 55 percent regardless of the facility's lower limit of normal (LLN). Patients with reproductive potential must agree to use an effective non-hormonal method of contraception during therapy and for at least 7 months after the last dose of study MAIN STUDY ENROLLMENT Tumor determined to have abnormal HER2-driven signaling activity based on the CELx HSF test. ______________

Exclusion Criteria:

T4 tumors including inflammatory breast cancer. FNA alone to diagnose the breast cancer. Excisional biopsy or lumpectomy performed prior to initiating chemotherapy. Surgical axillary staging procedure prior to initiating chemotherapy. Pre-neoadjuvant therapy sentinel node biopsy is not permitted. (FNA or core biopsy is acceptable.) Definitive clinical or radiologic evidence of metastatic disease. Required imaging studies must have been performed within 6 weeks prior to initiating chemotherapy. Synchronous bilateral invasive breast cancer. (Patients with synchronous and/or previous contralateral ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] are eligible.) Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.) Previous therapy with anthracycline, taxanes, trastuzumab, or other HER2 targeted therapies for any malignancy. Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. (These patients are eligible if this therapy is discontinued prior to initiating chemotherapy.) History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 2 years prior to initiating chemotherapy. Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to:
• Active cardiac disease: angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic pericarditis.
• History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function; history of documented congestive heart failure (CHF); and documented cardiomyopathy. Uncontrolled hypertension defined as sustained systolic BP greater than 150 mmHg or diastolic BP greater than 90 mmHg. (Patients with initial BP elevations are eligible prior to initiating chemotherapy if initiation or adjustment of BP medication lowers pressure.) Active hepatitis B or hepatitis C with abnormal liver function tests. Intrinsic lung disease resulting in dyspnea. Poorly controlled diabetes mellitus. Active infection or chronic infection requiring chronic suppressive antibiotics. Patients known to be HIV positive. Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) greater than or equal to grade 2, per the CTCAE v4.0. Malabsorption syndrome, ulcerative colitis, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal function. Other non-malignant systemic disease that would preclude treatment with any of the treatment regimens or would prevent required follow-up. Conditions that would prohibit administration of corticosteroids. Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids). Known hypersensitivity to any of the study drugs or any of the ingredients or excipients of these drugs (e.g., Cremophor EL), including sensitivity to benzyl alcohol. Pregnancy or lactation at the initiation of chemotherapy. (Note: Pregnancy testing must be performed within 2 weeks prior to initiating chemotherapy according to institutional standards for women of childbearing potential.) Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.

Interventions: Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: Weekly Paclitaxel, Drug: Trastuzumab, Drug: Pertuzumab, Diagnostic Test: Celcuity CELx HSF

Conditions: HER2-negative Breast Cancer

Keywords: NSABP, Celcuity, HER2-negative, invasive, breast cancer, Open-label, Neoadjuvant, Early stage, Doxorubicin, Cyclophosphamide, Paclitaxel, Trastuzumab, Pertuzumab, CELx HSF, HER2 Signaling Function test, anti-HER2 Antibodies

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A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines (RECLAIM)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06868212

Show full eligibility criteria

Inclusion Criteria:

* Adults ≥ 18 years of age at the time of signing the informed consent * CSU duration for ≥ 6 months prior to screening (defined as the onset of CSU determined by the Investigator based on all available supporting documentation) * Diagnosis of CSU inadequately controlled by sgH1-AH at the time of randomization, defined as: * The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of sgH1-AH during the 7 days prior to randomization (Day 1): * UAS7 score (range, 0-42) ≥ 16, and * ISS7 score (range, 0-21) ≥ 6, and * HSS7 score (range, 0-21) ≥ 6 * Documentation of hives within 3 months before randomization (either at screening and/or at randomization); or documented in the participants medical history * Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol * Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1)

Exclusion Criteria:

* Previous use of remibrutinib or other bruton's tyrosine kinase (BTK) inhibitors * Previous use of dupilumab * Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Visit 1), neurological, psychiatric, pulmonary, renal, hepatic (past history or current), endocrine or metabolic disorder, or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant. * Evidence of hematological disorders (including coagulation disorders or significant bleeding risk) * History or evidence of gastrointestinal disease (including gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion) * Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited. * Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants \[NOAC\]) * History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or hepatic parameters at screening: Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels more than 1.5x ULN or International Normalized Ratio (INR) \> 1.5 at screening

Interventions: DRUG: Remibrutinib, DRUG: Remibrutinib matching placebo, DRUG: Dupilumab, DRUG: Placebo solution for injection

Conditions: Chronic Spontaneous Urticaria (CSU)

Keywords: BTK inhibitor, chronic spontaneous urticaria, Urticaria activity score, Hives severity score, Itch severity score

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Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)

Contact(s):

clinicaltrials@northshore.org

Sex: ALL

Age: 4 weeks to 11 years old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT04375800

Show full eligibility criteria

Inclusion Criteria:

* Has human immunodeficiency virus type 1 (HIV-1) infection confirmed at screening * Has appropriate treatment history defined as treatment-naïve (TN) or with documented virologic suppression (HIV-1 ribonucleic acid \[RNA\] \<50 copies/mL) on stable combination antiretroviral therapy (cART) for ≥3 months * Body weight is \>3 kg to \<45 kg * If female, is not pregnant or breastfeeding, and one of the following applies: * Is not a woman of childbearing potential (WOCBP) * Is a WOCBP using an acceptable form of contraception, or is abstinent * If a WOCBP must have a negative pregnancy test (urine or serum) within 24 hours of the first dose of study intervention Study Extension

Inclusion Criteria:

* Has completed the Week 96 visit * Is considered, in the opinion of the investigator, to have derived benefit from treatment with doravirine (DOR) plus the 2 nucleoside/nucleotide analog reverse transcriptase inhibitor (NRTIs) selected by the investigator, or doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF), by Week 96 of the study * Is considered, in the opinion of the investigator, to be a clinically appropriate candidate for additional treatment with DOR regimens (DOR plus 2 NRTIs selected by the investigator or DOR/3TC/TDF) * Understands the procedures in the study extension and has provided (or have the participant's legally acceptable representative, if applicable, provide) documented informed consent/assent to enter the study extension and continue treatment with DOR regimens (DOR plus 2 NRTIs selected by the investigator or DOR/3TC/TDF) until it is available locally in countries participating in the study or for up to an additional 224 weeks (whichever comes first)

Exclusion Criteria:

* Has evidence of renal disease * Demonstrates evidence of liver disease * Has clinical or laboratory evidence of pancreatitis * Has any history of malignancy * Has presence of any active acquired immunodeficiency syndrome (AIDS)-defining opportunistic Infection * Has an active diagnosis of hepatitis, including hepatitis B co-infection * Has current active tuberculosis and/or is being treated with a rifampicin-containing regimen * Has a medical condition that precludes absorption or intake of oral pellets/granules * Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound results of the study or interfere with participating for the entire duration of the study * Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or other prohibited therapy * Is currently participating in or has participated in an interventional clinical study with an investigational compound or device from 45 days prior to Day 1 through the treatment period * Has a documented or known virologic resistance to DOR * Has any history of viremia (HIV RNA \>1000 copies/mL) after at least 3 months on a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen

Interventions: DRUG: Doravirine, DRUG: 2 NRTIs, DRUG: DOR/3TC/TDF

Conditions: Human Immunodeficiency Virus (HIV) Infection

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