Search Results
227results
ICU CONNECT: Study Comparing EMG in Healthy Volunteers and ICU Patients. (ICU CONNECT)
clinicaltrials@northshore.org
ALL
18 years to 90 years old
NA
NCT07699562
Inclusion Criteria:
* Cohort 1: Healthy volunteers
Inclusion criteria:
* Subjects must be \> 18 years old and \< 90 years old.
* Subjects must consent to participate. Cohort 2: Non-intubated critically ill patients
Inclusion criteria:
* Subjects may be male or female.
* Subjects must be \> 18 years old and \< 90 years old.
* Subjects must have a POA or next of kin who is able to consent (for those in the ICU and who are unable to consent themselves).
Cohort 3: Intubated critically ill patients
Inclusion criteria:
* Subjects may be male or female.
* Subjects must be \> 18 years old and \< 90 years old.
* Subjects must have a POA or next of kin who is able to consent (for those in the ICU and who are unable to consent themselves).
* For the Subjects in the ICU that are intubated, they must be planned to be intubated for at least 24 hours.
* Subjects must be intubated for no longer than ≥ 72 hours before enrollment.
Exclusion Criteria:
* Cohort 1: Healthy volunteers
Exclusion criteria:
* Subjects with previous paralysis or neuromuscular disease.
* Subjects with spinal cord or brain injuries that impact motor function.
* Subjects with an allergy to clinical adhesive or hydrogel. Cohort 2: Non-intubated critically ill patients
Exclusion criteria:
* Subjects with previous paralysis or neuromuscular diseases.
* Subjects with previous peripheral nerve injuries to the tested limbs.
* Subjects with spinal cord or brain injuries (including stroke) that impact motor function.
* Subjects without a POA or next of kin for those patients that are unable to consent themselves.
* Subjects with an allergy to clinical adhesive or hydrogel. Cohort 3: Intubated critically ill patients
Exclusion criteria:
* Subjects with previous paralysis or neuromuscular disease
* Subjects with previous peripheral nerve injuries to the tested limbs.
* Subjects with spinal cord or brain injuries that impact motor function.
* Subjects without a POA or next of kin for those patients that are in the intubated arm.
* Subjects with intubations expected to last less than 24 hours.
* Subjects who have already been intubated for \> 72 hours.
* Subjects with an allergy to clinical adhesive or hydrogel. DEVICE: TetraGraph, DEVICE: Electromyography, DEVICE: Nerve conduction studies
ICU Acquired Weakness
Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study (ALARION EV)
clinicaltrials@northshore.org
ALL
18 years and over
NA
NCT07324031
Inclusion Criteria:
• At least 18 years old
• Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines or ESC guidelines
Exclusion Criteria:
• Patients who cannot read or write
• Expected survival \< 1 year
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
• Participation in any concurrent clinical study without prior approval from the Sponsor
• Inability or unwillingness to provide informed consent to participate in the study
• Any known circumstances which may prevent the completion of protocol testing and data collection through the 6-month follow-up visit
• Circumstances that may prevent data collection or completion of specified follow-up visits
• Allergies to any device materials listed in the Instructions for Use (IFU)
• Contraindication for temporary suspension of oral/systemic anticoagulation
• Known history of lung disease with FEV1 \< 1.0 Liter Device Related:
• Implanted with or planned implantation of any device which delivers current in the body that may interfere with therapy delivery, including, but not limited to a pacemaker, LVAD or neurostimulator
• Implanted with a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads
• Any known need for MRI prior to approval of MRI conditional labeling Anatomy Related:
• Known structural abnormalities of the heart that may increase risk of the Parasternal EV-ICD System procedure
• Known obstructed or restricted pathway into the mediastinum for the Atala™ lead
• Prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium, including sternotomy of any type
• Known significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
• History of thoracic radiation therapy or other medical treatments/conditions which may complicate the Parasternal EV-ICD System implant procedure
• Known adhesions in the thorax or history of medical treatments, surgeries or conditions that increase the potential for adhesions in the thorax
• Surgically corrected congenital heart disease (not including catheter-based procedures) Cardiac Related:
• Indication for permanent bradycardia pacing or cardiac resynchronization therapy
• Decompensated heart failure
• Currently on inotropic therapy
• Known history of pericardial disease, pericarditis or mediastinitis
• Risk factors associated with defibrillation testing: * Severe aortic stenosis * Current Intracardiac LA or LV thrombus * Severe proximal three-vessel or left main coronary artery disease without revascularization * Hemodynamic instability * Unstable angina * Recent stroke or transient ischemic attack (within the last 3 months) * Known inadequate external defibrillation * LVEF \< 20% (most recent assessment; must be within 180 days of consent) * LVEDD \>70 mm (most recent assessment; must be within 180 days of consent)
DEVICE: Atala™ lead and EV-ICD Pulse Generator
Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia
Ventricular Defibrillation, Extravascular
A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Early-stage and Advanced HR+ Breast Cancer
clinicaltrials@northshore.org
FEMALE
18 years to 55 years old
PHASE1
NCT07310420
Inclusion Criteria:
• Age and gender: Female participants aged 18 to 55 years, inclusive.
• Hormone receptor positive (HR+): Either estrogen receptor positive (ER+) or progesterone receptor positive (PR+) breast cancer, defined as 1% to 100% of tumor nuclei are positive for ER or PR via immunohistochemistry.
• Participants must be of premenopausal status.
• Recent radiotherapy:
• Prior radiotherapy is allowed.
• All radiotherapy-related toxicities (except alopecia) must have recovered to Common Terminology Criteria for Adverse Events (CTCAE) v6.0 Grade ≤1 before trial enrollment.
• Concurrent medications:
• Cyclin-dependent kinase 4 (CDK4/6) inhibitors are permitted.
• PIK3CA/AKT inhibitors are permitted.
• Concomitant use of bisphosphonates is permitted.
• Concomitant use of endocrine therapy (eg, aromatase inhibitor, fulvestrant, or other FDA-approved selective estrogen receptor degrader \[SERDs\]) is permitted.
• Concurrent standard-of-care human epidermal growth factor receptor 2 (HER2)- targeted therapy (including but not limited to trastuzumab, pertuzumab, trastuzumab deruxtecan, or T-DM1) is permitted.
• Informed consent: Able to understand and willing to provide informed consent and able to comply with the trial procedures and restrictions.
• Abstinence and contraception: Female participants may be enrolled if they are:
• Practicing true abstinence for at least 28 days prior to investigational product (IP) administration until 12 weeks after the last IP administration and having a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day -1, OR
• Using 2 forms of highly effective nonhormonal contraception, including 1 physical barrier (condom or diaphragm) plus another nonhormonal method (eg, intrauterine device, spermicidals) from Screening or at least 2 weeks prior to IP administration (whichever is earlier) until 12 weeks after the last IP administration and having a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day -1.
• Performance status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Inclusion Criteria specific to the advanced breast cancer cohort:
• Advanced breast cancer diagnosis: Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent per investigator's assessment.
• Chemotherapy History:
• A participant may have received chemotherapy provided the criteria for premenopausal status, as defined in Inclusion Criterion #3, are met at trial screening.
• All chemotherapy-related toxicities must have recovered to CTCAE v6.0 ≤Grade 1 before trial participation, except for alopecia, peripheral neuropathy, or paresthesia (≤Grade 2).
• Prior treatment:
• Participants may have received prior radiotherapy.
• Participants may have received or be receiving a cyclin-dependent kinase (CDK) 4/6 inhibitor, a PIK3CA-AKT inhibitor, or bisphosphonates.
• Gonadotropin-releasing hormone (GnRH) treatment-naïve participants will have no history of GnRH agonist or other endocrine therapy in the advanced/metastatic setting.
• GnRH treatment-exposed participants may have received a GnRH agonist or other endocrine therapy in the advanced/metastatic setting, provided they had established premenopausal status (Inclusion Criterion #3) prior to initiating GnRH agonist therapy, within 6 months prior to trial enrollment.
• Participants may have received HER2-targeted therapy (including but not limited to trastuzumab, pertuzumab, trastuzumab deruxtecan, or T-DM1). Inclusion Criteria specific to the early-stage breast cancer cohort:
• Early-stage breast cancer diagnosis:
• Histologically confirmed unilateral or bilateral invasive adenocarcinoma of the breast.
• Pathologically staged as Stage I, II, or III (specifically T1-T4, N0-N3, M0) at the time of definitive surgery, according to the current American Joint Committee on Cancer (AJCC) Staging Manual.
• Chemotherapy history:
• A participant may have received adjuvant or neoadjuvant chemotherapy provided the criteria for premenopausal status, as defined in Inclusion Criterion #3, are met at trial Screening.
• All chemotherapy-related toxicities must have recovered to CTCAE v6.0 ≤Grade 1 before trial participation except for alopecia, peripheral neuropathy, or paresthesia (≤Grade 2).
• Prior treatment:
• Participants may have received prior radiotherapy.
• Participants may have received or be receiving a CDK 4/6 inhibitor, a PIK3CA-AKT inhibitor, or bisphosphonates.
• GnRH treatment-naïve participants will have no history of GnRH agonist or other endocrine therapy.
• GnRH treatment-exposed participants may have received a GnRH agonist or other endocrine therapy provided they had established premenopausal status (Inclusion Criterion #6) prior to initiating GnRH agonist therapy, within 6 months prior to trial enrollment.
• Participants may have received HER2-targeted therapy (including but not limited to trastuzumab, pertuzumab, trastuzumab deruxtecan, or T-DM1).
Exclusion Criteria:
• Postmenopausal: Naturally or surgically postmenopausal (regardless of age).
• Body mass index (BMI): \<18 kg/m\^2 or \>35.0 kg/m\^2.
• Prior surgical or radiation procedures: History of bilateral oophorectomy or prior radiotherapy to the ovaries.
• Selective estrogen receptor modulator (SERM) use during trial: Participants may not receive tamoxifen or other SERMs during the trial and must discontinue any SERMs prior to enrollment, other endocrine therapies (eg, aromatase inhibitor, fulvestrant, or other FDA-approved SERDs) are allowed.
• Hypersensitivity: Known hypersensitivity, idiosyncratic, or allergic reactions to goserelin, GnRH, GnRH agonists/analogs, or any trial drug components.
• Expected survival: Estimated life expectancy \<6 months from the start of trial therapy, based on the principal investigator's (PI) clinical judgment.
• Performance status: ECOG performance status ≥3.
• Life-threatening disease or metastasis: Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, symptomatic pulmonary lymphangitic spread, symptomatic pleural disease, or any symptomatic brain/leptomeningeal metastases (proven or suspected). Participants with asymptomatic or stable/treated brain metastases are eligible to enroll if neurologically stable and are receiving a stable or decreasing corticosteroid dose at the time of enrollment. Participants with discrete pulmonary parenchymal metastases are eligible if respiratory function is not compromised.
• Hepatic function:
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2×upper limit of normal (ULN) if no liver metastases, or \>5×ULN with liver metastases.
• Total bilirubin ≥1.5×ULN (≥2.5×ULN for Gilbert's syndrome).
• Renal function: Creatinine clearance (CrCl) ≤30 mL/min as calculated by the Cockcroft-Gault formula.
• Hematologic parameters:
• Hemoglobin (Hgb) \<8.0 g/dL.
• White blood cell (WBC) count \<3000/mm\^3.
• Platelets \<100,000/mm\^3.
• Eligibility for participants taking CDK4/6 inhibitors should be based on D-1 labs.
• An absolute neutrophil count (ANC) \<1500/mm3 on D-1 is exclusionary.
• Other malignancies: Active malignancy within the past 3 years, except for adequately treated basal or squamous cell skin cancer or in situ cervical carcinoma.
• Concurrent medical conditions: Presence of any severe, uncontrolled, or serious illness, medical condition (including psychiatric/addictive disorders), or clinical finding that could compromise trial adherence, as assessed by the investigator.
• Investigational drug exposure: Exposure to any investigational drug or device within 30 days prior to trial enrollment.
• Pregnancy: Participant has childbearing potential with a positive serum pregnancy test or positive urine pregnancy test at Screening or Day 1.
• Breastfeeding: Participant is currently breastfeeding.
• Contraceptive use: Sexually active with a male partner and not willing to use nonhormonal contraceptive methods throughout the trial. Exceptions: male partner is vasectomized (provided he is her sole sexual partner, and he has received medical assessment of the surgical success), participant has had bilateral salpingectomy or tubal occlusion hysterectomy.
• Cardiac conditions:
• Corrected QT interval (QTc) using Fridericia's correction (QTcF) \>450 ms at Screening.
• Uncontrolled or symptomatic heart disease, including: i. New York Heart Association (NYHA) Class III or IV heart failure. ii. Myocardial infarction within the past 6 months. iii. Unstable angina or significant arrhythmias requiring intervention. c. Documented congenital QT syndrome.
• Clinically relevant abnormal medical history or abnormal findings on physical examination, vital signs, echocardiogram (ECG), or laboratory tests at Screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant.
• History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
• History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within the last 1 year prior to IP administration.
• Major surgery within 30 days prior to IP dosing or a major surgical procedure planned during the trial.
• Any other condition that precludes adequate understanding, cooperation, and compliance with trial procedures or any condition that could pose a risk to the participant's safety, as per the investigator's judgment.
DRUG: ZOLADEX
Advanced Breast Cancer, Early Breast Cancer
Ovarian Suppression, ZOLADEX, HR+, Breast Cancer, Goserelin Implant
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes (Enith1)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT07351045
Inclusion Criteria:
* Participants must have at screening:
• Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or
• BMI ≥27.0 kg/m\^2 and \<30.0 kg/m\^2 with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, or weight-related cardiovascular disease * History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight * Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
Exclusion Criteria:
* History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma. Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since.
* Self-reported change in body weight \>5 kg within 3 months prior to screening
* Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
* Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
* Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
* History of acute or chronic pancreatitis or clinically significant gallbladder disease. History of acute pancreatitis caused by gallstones or clinically significant gallbladder disease is allowed if the participant had a cholecystectomy to resolve the problem at least 3 months prior to screening.
* Poorly controlled hypertension at screening
* Any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure.
* Have a history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder). Participants with MDD or generalized anxiety disorder whose disease state is considered stable within 1 year prior to screening and expected to remain stable throughout the course of the study, in the opinion of the investigator, are allowed provided that they are not receiving prohibited medication.
* Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization COMBINATION_PRODUCT: Placebo, COMBINATION_PRODUCT: Enicepatide
Obesity or Overweight
Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)
clinicaltrials@northshore.org
ALL
18 years and over
NCT07101094
Inclusion Criteria:
* Aged ≥18 years at index date.
* Have a confirmed diagnosis of schizophrenia before index date.
* Receipt of an initial prescription order for xanomeline and trospium chloride (XT) and plan to fill and initiate such therapy.
* Provide a signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF) in accordance with regulatory, local, and institutional guidelines.
* Agree to use an electronic device to record, or provide paper entry of, patient-reported outcomes (in English or Spanish).
* English or Spanish speaking.
Exclusion Criteria:
* Participation in an interventional study within the last 30 days or plan to participate in such study at the time of eligibility screening.
* Evidence of use of XT prior to time of eligibility screening. DRUG: xanomeline and trospium chloride (X/T) therapy
Schizophrenia
Schizophrenia
Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes (CLARITY)
clinicaltrials@northshore.org
ALL
18 years to 70 years old
NCT06661850
Inclusion Criteria:
• Subject is a skeletally mature male or female (non-pregnant) aged 18 to 70 years (inclusive);
• Subject plans to undergo surgical treatment of their discogenic back pain independent of this research protocol;
• Subject is to be treated with on-label use of FDA-cleared or FDA-approved devices independent of this research protocol;
• Subject has a diagnosis of discogenic back pain that requires treatment in up to two lumbar levels caused by degenerative disc disease (identified via MRI);
• Subject has a preoperative Oswestry Disability Questionnaire score ≥35 out of 100 points (35/100);
• Subject has a VAS back pain score of ≥40mm and that is greater than the worst VAS leg pain score;
• Subject has failed at least ≥ 6 months of non-operative treatment (for example: physical therapy, bed rest, anti-inflammatory or analgesic medications, chiropractic care, acupuncture, massage therapy or home-directed lumbar exercise programs) OR requires urgent surgical treatment per the investigator;
• Subject has signed the IRB approved Informed Consent Form; and
• Subject is psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
Exclusion Criteria:
• Subject has a primary diagnosis of spinal condition other than degenerative disc disease at the involved level (i.e., facet joint pain/SI pain);
• Subject has had prior lumbar back surgery or intradiscal treatments at any lumbar level (Note: diagnostic provocative or anesthetic discography are not excluded; micro-discectomy, decompression, or laminectomy patients greater than 6 months postop are not excluded);
• Surgery is planned for more than 2 lumbar levels.
• Subject has severe spinal canal stenosis as assessed by the Investigator;
• Subject has a motor strength deficit(s) in lower extremities
• Subject has a lumbar spine diagnosis, based on radiographic evidence, of clinically relevant lumbar vertebral abnormalities (except Modic end-plate changes, which are not excluded), including: * Spondylolisthesis Grade 2 or greater (up to Grade 1 is accepted) * Pars fracture, at the involved level * Spondylolysis * Lumbar scoliosis with a Cobb angle of greater than 15° * Evidence of prior fracture or trauma to the L1, L2, L3, L4, or L5 levels in either compression or burst * Lumbar kyphosis
• Subject has radiologic evidence of an uncontained lumbar disc herniation or lumbar disc extrusion.
• Subject is contraindicated for a standard lumbar MRI exam
• Women who are currently pregnant (or believe they may be at risk of being or becoming pregnant), or are breast feeding, during the study period when scans will be performed
• Subject is currently receiving worker's compensation or is involved in in any litigation for personal injury, medical negligence, trauma, or worker's compensation.
• Subject has a chronic disease (other than degenerative disc disease), chronic pain (other than discogenic low back pain), or psychological dysfunction, which may, in the opinion of the Principal Investigator, compromise a subject's ability to comply with study procedures, and/or may confound data
• Subject has a BMI \> 40
PROCEDURE: Fusion or TDR determined by investigator.
Discogenic Low Back Pain
MR Spectroscopy, MRI, back pain, Nociscan
A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation (PERSIGMA RCT)
clinicaltrials@northshore.org
ALL
18 years to 80 years old
NA
NCT07523750
Inclusion criteria:
* Participant has been diagnosed with symptomatic persistent atrial fibrillation (PsAF), which is defined as continuous atrial fibrillation (AF) sustained beyond 7 days and less than 365 days in duration documented by: i. A physician's note documenting diagnosis of symptomatic PsAF as defined above and ii. Two electrocardiograms showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be greater than \[\>\] 365 days prior to enrollment) or iii. A 24-hour arrhythmia monitor documenting continuous AF within the last 365 days
* Participant is aged 18 - 80 years at the time of informed consent
* Participant is willing and capable of providing informed consent
* Participant is able and willing to comply with all pre-, post- and follow-up testing and requirements
Exclusion criteria:
* Participant has continuous AF \> 365 days (longstanding persistent AF)
* Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, etc.)
* Participant has had previous surgical or catheter ablation for AF
* Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and the cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
* Participant has severe dilatation of the LA (LAD \> 50 millimeters \[mm\]) of the antero-posterior diameter confirmed by imaging performed within 180 days prior to enrollment
* Participant has LA thrombus confirmed by imaging within 48 hours prior to the procedure
* Participant has severely compromised Left Ventricular Ejection Fraction (LVEF less than \[\<\] 40%) confirmed by imaging performed within 180 days prior to enrollment
* Participant has uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
* Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin)
* Participant has had a thromboembolic event (including TIA) within the past 180 days prior to enrollment
* Participant has had a percutaneous coronary intervention or acute MI within past 60 days prior to enrollment
* Participant has had coronary artery bypass grafting (CABG) surgery within the past 180 days prior to enrollment
* Participant has had valvular cardiac surgical/percutaneous procedure (that is, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)
* Participant has unstable angina within past 6 months prior to enrollment
* Participant has anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 365 days post-procedure
* Participant has significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
* Participant has a significant congenital anomaly (for example, atrial septal defects \[ASDs\]) including repaired defects or medical problems that in the opinion of the Investigator would preclude enrollment in this study
* Participant has an existing diagnosis of pulmonary vein stenosis (PVS)
* Participant has a pre-existing hemi-diaphragmatic paralysis
* Participant has an acute illness, active systemic infection, or sepsis
* Participant has an intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
* Participant has severe mitral regurgitation (regurgitant volume greater than or equal to \[\>=\] 60 milliliters \[mL\]/beat, regurgitant fraction \>= 50 percent \[%\], and/or effective regurgitant orifice area \>= 0.40 square centimeter \[cm\^2\])
* Participant has an implanted metal cardiac device, including MitraClip and left atrial appendage occlusion (LAAO) devices (for example, WATCHMAN, Amulet, etcetra.) and/or a double-coiled implantable cardioverter-defibrillators (ICD), (this exclusion does not include coronary stents, implanted pacemakers, single-coiled ICD and implantable loop recorders \[ILR\])
* Participant has a condition that precludes vascular access (such as inferior vena cava \[IVC\] filter)
* Participant is currently enrolled in an investigational study evaluating another device or drug
* Participant is pregnant, lactating, or is of child-bearing potential and plans on trying to become pregnant during the course of the clinical investigation
* Participant has a life expectancy less than 365 days
DEVICE: VARIPULSE Catheter, DEVICE: FARAWAVE Catheter
Atrial Fibrillation
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT07675135
Inclusion Criteria:
* Has a current documented diagnosis of NT1 or NT2 per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or the ICSD-3 Text Revision (ICSD-3-TR) within the last 10 years.
* Has EDS.
* If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants or wake-promoting agents, must be on a stable dose for at least 3 months prior to Screening and agree to continue at that stable dose for the Double-blind Treatment Period of the study. As needed (PRN) use of any treatment that could affect daytime sleepiness (including but not limited to oxybates, stimulants, modafinil, and armodafinil) is not permitted.
Exclusion Criteria:
* Has hypersomnia due to another medical disorder.
* Has a history of pitolisant use within 5 half-lives prior to Screening.
* Has a primary diagnosis of psychiatric illness, including depression, that is not well controlled (i.e., symptoms and medications have not been stable for at least 3 months prior to Screening).
* Has any history of bipolar disorder or psychosis
* Has acute or chronic liver disease or a history of moderate or severe hepatic impairment.
* Has a body surface area-corrected estimated glomerular filtration rate (eGFR) \<60 mL/min.
* Has a known history of long QT syndrome or serious abnormality of the electrocardiogram (ECG). DRUG: HBS-301, OTHER: Placebo
EDS, Cataplexy, Fatigue, Narcolepsy
pitolisant, HBS-301, narcolepsy, EDS, cataplexy, fatigue
Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer (RAINFOL-03)
clinicaltrials@northshore.org
FEMALE
18 years and over
PHASE3
NCT07166094
Key Inclusion Criteria
* Participants must have histologically or cytologically confirmed recurrent or progressive endometrial cancer (EC; any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.
* Participants must have received at least 1, but not more than 3, prior lines of therapy:
* Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in combination
* If the tumor recurred more than 12 months after completion of platinum-based chemotherapy, additional platinum-based chemotherapy must be administered for recurrent disease unless the participant is ineligible for further platinum-based chemotherapy, in which case the reason for ineligibility must be documented.
* Note: If Immunotherapy-based treatment is administered in the advanced/recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from prior platinum-based chemotherapy. In such cases, the reason for ineligibility for platinum-based chemotherapy must be documented.
* Prior induction plus maintenance is considered 1 line of therapy
* Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.
* Therapy changed due to toxicity in the absence of progression will be considered part of the same line of therapy (i.e., will not be counted independently as a separate line of therapy)
* Participants must have progressed radiographically on or after their most recent line of therapy
Key Exclusion Criteria
* Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.
* Has a past or current malignancy other than the inclusion diagnosis before the planned first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated cervical carcinoma of Stage 1B or less, noninvasive basal cell or squamous cell skin carcinoma, noninvasive superficial bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥3 years (i.e., eligible participants must have complete response of ≥3 years duration).
* Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after completion of brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the planned first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.
* Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility.
Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
DRUG: Rina-S, DRUG: IC
Endometrial Cancer, Recurrent or Progressive Endometrial Cancer
An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS
clinicaltrials@northshore.org
ALL
18 years to 100 years old
PHASE3
NCT07665437
Key
Inclusion Criteria:
* Signed informed consent must be obtained before any assessment is performed.
* Participant has completed the full study treatment period according to the protocol (68 weeks) in the core studies (CLOU064J12301 or CLOU064J12302).
* Participant does not meet any treatment discontinuation criteria of the core study at Week 68.
Key Exclusion Criteria:
* Ongoing or planned use of prohibited HS or non-HS treatments.
* Participants not expected to benefit from participation in the extension study or participants expected to be exposed to an undue safety risk if participating in the extension study, as assessed by the Investigator.
* Current severe progressive or uncontrolled disease, which in the judgment of the Investigator renders the participant unsuitable for the study.
Other protocol-defined inclusion/exclusion criteria may apply. DRUG: Remibrutinib
Hidradenitis Suppurativa
BTK inhibitor, hidradenitis suppurativa, HiSCR, remibrutinib, Phase 3, extension study
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT07174336
Inclusion Criteria:
* Are willing to follow contraception requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials.
* If assigned female at birth, pre-/peri- and postmenopausal status is allowed. Those with pre- or peri-menopausal status at study entry must agree to use ovarian function suppression with any locally approved gonadotropin-releasing hormone (GnRH) agonist.
* If assigned male at birth with an estrogen receptor positive (ER+) breast cancer diagnosis, they must agree to use hormone suppression with a GnRH agonist.
* Have histologically or cytologically confirmed breast cancer, defined as individuals with
* locally advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease, and
* hormone receptors (HR)+/human epidermal growth factor receptor 2 (HER2)- or HR+/HER low defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines
* HR status: Documented ER+ and/or progesterone receptor-positive (PR+) tumor according to ASCO/CAP Guidelines, defined as greater than or equal to (≥)1 percent (%) of tumor cells stained positive based on the most recent tumor biopsy and assessed locally
* HER status: immunohistochemistry score of 1+ or score of 2+ with a negative Fluorescence In Situ Hybridization (FISH) based on local results as defined in the ASCO/CAP Guidelines
* Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay.
* Have measurable disease or non-measurable, evaluable bone disease
* Part 1:
* Received 0-2 prior systemic treatments for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease.
* Up to 1 of these prior systemic treatments may contain chemotherapy
* Part 2:
* Received 0 prior systemic treatment for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease.
* Individuals who are eligible are either
* Population 1 (P1): Endocrine sensitive
* newly diagnosed with advanced breast cancer (de novo)
* participants with a history of HR+, HER2- EBC and did not receive SOC adjuvant ET
* relapsed with documented evidence of progression greater than (\>)12 months from completion of (neo)adjuvant ET ± cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, or
* Population 2 (P2): Endocrine resistant
* relapsed with documented evidence of progression less than or equal to (≤)12 months of completing (neo)adjuvant ET ± CDK4/6 inhibitor.
* if a CDK4/6 inhibitor was included as part of neoadjuvant or adjuvant therapy, progression event must be \>12 months since completion of CDK4/6 inhibitor portion of neoadjuvant or adjuvant therapy.
Exclusion Criteria:
* Have an established diagnosis of Type 1 diabetes mellitus or Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥8%, fasting blood glucose (FBG) ≥140 milligrams per deciliter (mg/dL) (7.7 millimoles per liter \[mmol/L\]), or requiring insulin.
* Have inflammatory or metaplastic breast cancer.
* History of leptomeningeal disease or carcinomatous meningitis.
* Have known and untreated or active central nervous system (CNS) metastases. Exception: Asymptomatic brain or spinal metastases if treated by surgery, surgery plus radiotherapy, or radiotherapy alone with no evidence of radiographic progression or hemorrhage within at least 28 days before randomization and no requirement for anticonvulsants or systemic corticosteroids for at least 28 days before randomization.
* Have received treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to randomization up to a maximum washout period of 28 days.
* Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dose more than 10 milligrams \[mg\] daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.
* Are pregnant, breastfeeding, or intend to become pregnant during the study or within 6 months of the last dose of study intervention and at least 2 years after the last dose of fulvestrant and/or CDK4/6 inhibitor after the final administration of study treatment.
* Have active bacterial or fungal infection that is not recovered at randomization. DRUG: LY4064809, DRUG: Placebo, DRUG: Ribociclib, DRUG: Palbociclib, DRUG: Abemaciclib, DRUG: Anastrozole, DRUG: Letrozole, DRUG: Exemestane, DRUG: Fulvestrant
Breast Neoplasms, Neoplasm Metastasis
STX-478, PI3K
A Study in Young People and Adults to Learn About the Medicine Ritlecitinib for Treatment of Patchy Hair Loss, Known by the Medical Term as Moderate Alopecia Areata
clinicaltrials@northshore.org
ALL
12 years and over
PHASE3
NCT07733765
Key Inclusion Criteria
* 18 years or older (or the minimum age of consent in accordance with local regulations) at screening. Adolescents (12 to \<18 years of age at screening) are also eligible for this study, but only if permitted by the local IRB/EC and local regulatory health authority (if applicable). Where these approvals have not been granted, only participants 18 years of age and older at screening will be enrolled
* Have a clinical diagnosis of AA with no other etiology of hair loss.
* Have \>20% to \<50% hair loss of the scalp, as measured by SALT.
* Current AA episode of hair loss ≥6 months and ≤10 years (Current episode is defined as the continuous period of AA-related scalp hair loss since the last time the subject had no visible scalp patches).
Key Exclusion Criteria
1\. Diseases or conditions affecting hair loss, including:
* Other types of alopecia (including, but not limited to, traction and scarring alopecia, telogen effluvium). Participants with androgenetic alopecia will be excluded.
* Other scalp disease that may impact AA assessment (eg, scalp psoriasis, dermatitis, etc.).
* Active systemic diseases that may cause hair loss (eg, lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc).
DRUG: Ritlecitinib 100 mg, DRUG: Ritlecitinib 50 mg, OTHER: Placebo
Alopecia Areata
Use of PuraStat Following Aquablation to Determine if There is Change in Hematuria & Probability of Same Day Discharge (PuraStat)
Pooja Research Manager, MS MHA - PTalaty@northshore.org
MALE
18 years and over
NA
NCT07789041
Inclusion Criteria:
• Subject must be undergoing Aquablation
• Subject is willing to comply with protocol requirements
Exclusion Criteria:
• Any significant medical condition which, in the attending physician's opinion, may interfere with the patient's optimal procedure
• Known or suspected systemic or severe infection
• Patient unable to give consent
DEVICE: PuraStat hydrogel and the syringe
BPH (Benign Prostatic Hyperplasia), BPH With Symptomatic Lower Urinary Tract Symptoms
PuraStat,Aquablation, BPH, Lower urinary tract symptoms
A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System (AdmIREPAS)
clinicaltrials@northshore.org
ALL
22 years and over
NA
NCT07227532
Inclusion Criteria:
* Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF
* Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I/III antiarrhythmic drugs (AAD)
* Willing and capable of providing consent
* Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion Criteria:
* Previously diagnosed with persistent or long-standing persistent AF (more than \[\>\] 7 days in duration)
* Previous surgical or catheter ablation for AF
* Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF
* Current enrollment in an investigational study evaluating another device or drug
* Life expectancy less than 12 months
* Any contraindications as defined in the Protocol DEVICE: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
Atrial Fibrillation
A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer
clinicaltrials@northshore.org
MALE
18 years and over
PHASE2
NCT05726292
Inclusion Criteria:
• Histologically or cytologically confirmed prostatic adenocarcinoma without primary small cell histology
• Localized disease: * Surgical resectability must be documented prior to enrollment * No evidence of distant metastatic disease on abdominopelvic imaging, bone imaging * Enlarged lymph nodes below the iliac bifurcation (clinical stage N1) is allowed * Either cross-sectional abdominopelvic imaging + technetium bone scan or PSMA PET imaging will be acceptable to rule out distant metastatic disease
• High or very high-risk disease (https://www.nccn.org/professionals/physician\_gls/pdf/prostate.pdf) as defined by having one or more of the following: * Clinical T3a or higher * Histologic Grade Group 4 or 5 * PSA \>20
• Eastern Cooperative Oncology Group performance status ≤ 1 (Appendix A)
• Total serum testosterone 100 ng/dL
• Patients must have normal hepatic function as defined below: * Total bilirubin \<1.5 X the upper limit of normal (note that in subjects with Gilbert's syndrome, if total bilirubin is \>1.5 X ULN, measure direct and indirect bilirubin. If direct bilirubin is ≤1.5 X ULN, the subject may be eligible) * AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal * Albumin 3.0 g/dL
• Patients must have normal bone marrow function as defined below: * Platelet count (plt) 100,000 /L * Hemoglobin (Hgb) 10 g/dL * Absolute neutrophil count (ANC) 1500
• Patients must have adequate renal function as defined below: • glomerular filtration rate (GFR) 30 mL/min
• Ability to understand and the willingness to sign a written informed consent document.
• Patients with active diabetes mellitus on glucose lowering medications are eligible provided they agree to and are able to self-monitor daily blood glucose levels due to potential risk of lowering glucose levels on relacorilant.
• Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration. Two acceptable methods of birth control thus include the following: * Condom (barrier method of contraception) AND * One of the following is required:
• Established use of oral, injected or implanted hormonal method of contraception by the female partner;
• Placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner;
• Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female partner;
• Tubal ligation in the female partner;
• Vasectomy or other procedure resulting in infertility (e.g., bilateral orchiectomy), for more than 6 months.
• 2 Exclusion Criteria
• Therapy with ANY hormonal therapy for prostate cancer (prior 5-alpha-reductase inhibitors for benign prostate disease is allowed but must be discontinued prior to study initiation).
• Inability to swallow capsules or known gastrointestinal malabsorption.
• History of other malignancies, with the exception of: adequately treated non-melanoma skin cancer, adequately treated superficial bladder cancer, stage 1 or 2 malignancies that are without evidence of disease, or other cancers curatively treated with no evidence of disease for \> 5 years from enrollment.
• Blood pressure that is not controlled despite \> 2 oral agents (SBP \>160 and DBP \>90 documented during the screening period with no subsequent blood pressure readings \>160/100).
• History of seizure disorder or active use of anticonvulsants. Medications used to treat neuropathic pain such as gabapentin or pregabalin are allowed.
• Serious inter-current infections or non-malignant medical illnesses that are uncontrolled.
• Active psychiatric illness/social situations that would limit compliance with protocol requirements.
• New York Heart Association (NYHA) class II, class III, or IV congestive heart failure (any symptomatic heart failure).
• Concurrent therapy with strong inhibitors of Cytochrome P450 3A4 or CYP2C8 due to concerning possible drug-drug interactions.
• Concurrent therapy with strong inducers of Cytochrome P450 3A4 due to concerning possible drug-drug interactions.
• Presence of concurrent medical conditions requiring systemic glucocorticoids for immunosuppression (e.g. autoimmune diseases, organ transplantation) that is active and has required glucocorticoids in the last 6 months.
DRUG: Relacorilant, DRUG: Enzalutamide, OTHER: Placebo (Sugar Pill), OTHER: Androgen Deprivation Therapy, PROCEDURE: Radical Prostatectomy
Prostate Cancer, Prostate Adenocarcinoma
prostate cancer
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)
clinicaltrials@northshore.org
ALL
18 years to 99 years old
PHASE3
NCT07684235
Inclusion Criteria:
* Signed informed consent form (ICF) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
* Completed the parent trial (2010181)
* Completed week 72 visit in parent trial
* Did not permanently discontinue trial intervention in parent trial
* Randomized within 7 Days of week 72 visit in the parent trial
* Participants must use protocol-specified contraception during treatment, and for an additional 16 weeks after the last dose of trial intervention
Exclusion Criteria:
* Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity
* Body mass index ≤ 18.5 kilograms per meter square (kg/m\^2)
* Participant has known sensitivity to any of the products or components to be administered during dosing
* History of ischemic optic neuropathy
* Any malignancy diagnosed during parent trial (20210181) except for the following treated with curative intent: nonmelanoma skin cancers, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ.
* Newly identified (i.e., identified during 20210181) multiple endocrine neoplasia syndrome type 2 or family (first-degree relative\[s\]) history of medullary thyroid cancer.
* Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at week 72 visit from parent trial before randomization
* Any suicidal ideation of category 4 or 5 OR any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit version at week 72 visit from parent trial before randomization.
* Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator.
* History or evidence of any other clinically significant disorder, condition, or disease (including, but not limited to known drug or alcohol abuse, eating disorders, and conditions identified during the parent trial) that, in the opinion of the investigator, would pose a risk to participant safety.
* Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or
* Planning to become pregnant or breastfeed while on trial until an additional 16 weeks after the last dose of trial intervention.
* Major surgical procedures planned during the trial.
* Participants with minor surgical procedures (not requiring general anesthesia or deep sedation) planned during the trial may be eligible at the discretion of the investigator.
* Investigative site personnel directly affiliated with the trial and/or their immediate family (ie, spouse, parent, child, or sibling, whether biological or legally adopted). DRUG: Maridebart cafraglutide, DRUG: Placebo
Obesity, Overweight
Overweight, BMI, Obesity, Maridebart cafraglutide, Chronic weight management, MariTide, Extension, Long-Term
Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-3) (COVE-3)
clinicaltrials@northshore.org
ALL
2 years and over
PHASE3
NCT07637734
Inclusion Criteria:
Candidates will be included in the study if they:
• Are male or female patients ≥ 2 years of age.
• Are immunocompetent.
• Have a minimum of 1 treatable common wart (verruca vulgaris) of any size and height:
• Common warts are considered treatable if they are located anywhere on the body, except for the following excluded areas: the eye area (including eyelids), lips, oral cavity, nasal cavity, inside of the ears, soles of the feet (plantar warts), subungual spaces (ie, under the fingernail or toenail), or the anogenital area (warts within 10 mm of a mucosal surface should not be treated).
• Common warts located in excluded areas (warts within 10 mm of a mucosal surface) will not be treated or evaluated in this study. Warts that are genital, plantar, or anal are not considered common warts and are thus excluded from treatment and evaluation in this study. A subject will not be excluded from the study if they have these types of warts, but the subject must also have warts that meet the inclusion criteria. • If treatment of these excluded wart types is required during the study, it should be limited to destructive therapy such as cryosurgery and warts cannot be within 10 mm of any warts that are under study.
• Have no systemic or dermatologic disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs.
• Agree to refrain from swimming, bathing, or prolonged immersion in water or any liquids until the study drug is removed after each treatment.
• Have the ability, or have a parent/guardian with the ability, to follow study instructions and the willingness to complete all study requirements.
• Agree not to use any wart-removing product (prescription or over-the-counter) other than the study drug during the course of the study, with the exception of circumstances allowed under Inclusion Criterion 3b.
• Provide written informed consent or assent in a manner approved by the IRB and/or have a parent/guardian provide written informed consent as evidenced by the signature on an IRB approved assent/consent form. Subjects who turn 18 years of age (or legal age per state or country) during the study will be required to re-consent to remain on the study.
• Provide written authorization for use and disclosure of protected health information (per state and/or country requirements).
• If participating in the optional photographic assessment, agree to allow photographs of treatable common warts to be taken at selected visits by the research team.
Exclusion Criteria:
Candidates will be excluded from the study if they:
• Are unable to cooperate with the requirements or visits of the study, as determined by the Investigator.
• Have any warts present at Baseline in an allowed anatomic location that the subject, parent/guardian, or Investigator is unwilling to treat.
• Plantar warts and external genital warts will not be included in this study, in addition, subungual warts and warts within 10 mm of a mucosal surface will not be included in this study due to their anatomical location and complex treatment modalities.
• Are systemically immunosuppressed or have taken required systemic immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) within 30 days before enrollment or such treatment is planned to be required during the course of the study. Routine use of local (eg, topical, inhaled, intranasal) corticosteroids and episodic use of systemic medications to treat conditions arising during the study is allowed.
• Have any chronic or acute medical condition that, in the opinion of the Investigator, may interfere with the study results or place the subject at undue risk (eg, human immunodeficiency virus, systemic lupus erythematosus, viral hepatitis, uncontrolled diabetes).
• Have had any previous treatment (including an investigational agent in a clinical trial) of common warts, including but not limited to the use of cantharidin, imiquimod, antivirals, retinoids, topical salicylic acid, lactic acid, hydrogen peroxide, trichloroacetic acid, pulse dye laser, iodine-based or nitric oxide-based therapies, oral cimetidine, coix seed, intralesional immunotherapy, curettage, or freezing of warts in the 30 days before treatment.
• Have more common warts, or wart area, to be treated than can be adequately covered with the contents of 2 study drug applicators, as determined by total wart surface area. Each applicator can cover approximately 1500 mm2 for a total of approximately 3000 mm2 using the 2 study drug applicators.
• Immunizations (eg, flu shots) may be administered throughout the study, but not within 5 days before or after any treatment with study drug and will be recorded as concomitant therapies in the eCRF.
• Have received any investigational product as part of a clinical trial NOT related to the treatment of common warts within 30 days before the first application of the study drug.
• Have epidermodysplasia verruciformis.
• Have an active malignancy or are undergoing treatment for any malignancy other than basal cell carcinoma.
• Have a history or presence of clinically significant medical, psychiatric, or emotional condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data.
• Have a history or presence of hypersensitivity or an idiosyncratic reaction to the study drug or related compounds, or drug product excipients (acetone, ethyl alcohol, nitrocellulose, hydroxypropyl cellulose, castor oil, camphor, gentian violet, and denatonium benzoate).
• Have a condition or situation that may interfere significantly with the subject's participation in the study (eg, subjects who required hospitalization in the 2 months before screening for an acute or chronic condition including alcohol or drug abuse), as determined by the Investigator.
• Are sexually active or may become sexually active and are unwilling to practice a highly effective method of birth control (eg, combination of condoms and foam; oral contraceptives; intrauterine device with or without hormone release; transdermal, injectable, or intravaginal contraception). Withdrawal is not an acceptable method of birth control. Females who have reached menarche must have a negative urine pregnancy test at each visit before treatment with study drug.
• Are pregnant or breastfeeding.
COMBINATION_PRODUCT: VP-102 (US) / TO-208 (Japan), COMBINATION_PRODUCT: Vehicle (US) / Vehicle (Japan)
Common Warts, Common Warts (Verruca Vulgaris), Human Papilloma Virus (HPV), Warts
Common Warts, Common Warts (Verruca Vulgaris), Human Papilloma Virus (HPV)