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Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
clinicaltrials@northshore.org
ALL
18 years to 100 years old
PHASE2
NCT06865651
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.
DRUG: Remibrutinib, DRUG: Placebo
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
Remibrutinib, LOU064, Chronic urticaria, CINDU, CSU, Symptomatic dermographism, Cold urticaria, Cholinergic urticaria, Heat urticaria, Solar urticaria, Delayed pressure urticaria, Aquagenic urticaria, Contact urticaria
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD) (EMBARQ)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT07266402
Key
• Males and females, \>/= 18 years of age.
• Diagnosis of cold induced urticaria or symptomatic dermographism \>/= 3 months.
• Diagnosis of cold induced urticaria or symptomatic dermographism despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
• The presence of hives for \>/= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines.
• Must be on a stable regimen of second generation non-sedating H1-antihistamine for \>/= 4 weeks prior to study treatment.
• Cold induced urticaria: A Critical Threshold Temperature (CTT) of ≥ 10 °C and \< 37 °C using the TempTest® and a numerical rating scale score of ≥ 3 for itch after the provocation test.
• Symptomatic dermographism: A Critical Friction Threshold (CFT) of ≥ 3 using the FricTest® and a numerical rating scale score of ≥ 3 for itch after the provocation test.
• Cold induced urticaria: Positive ice-cube test resulting in hives at the provocation site during Screening
• Normal blood counts and liver function tests.
• Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
• Willing and able to complete a daily symptom electronic diary and comply with study visits.
• Participants with and without prior biologic experience are eligible. Key
• Women who are pregnant or nursing.
• Clearly defined cause for chronic urticaria.
• Active, pruritic skin condition in addition to cold induced urticaria or symptomatic dermographism.
• Medical condition that would cause additional risk or interfere with study procedures.
• Known HIV, hepatitis B or hepatitis C infection.
• Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine.
• History of anaphylaxis, unless due to cold exposure over a large part of the body (such as swimming in cold water).
• Prior treatment with barzolvolimab There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Inclusion Criteria:
• Males and females, \>/= 18 years of age.
• Diagnosis of cold induced urticaria or symptomatic dermographism \>/= 3 months.
• Diagnosis of cold induced urticaria or symptomatic dermographism despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
• The presence of hives for \>/= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines.
• Must be on a stable regimen of second generation non-sedating H1-antihistamine for \>/= 4 weeks prior to study treatment.
• Cold induced urticaria: A Critical Threshold Temperature (CTT) of ≥ 10 °C and \< 37 °C using the TempTest® and a numerical rating scale score of ≥ 3 for itch after the provocation test.
• Symptomatic dermographism: A Critical Friction Threshold (CFT) of ≥ 3 using the FricTest® and a numerical rating scale score of ≥ 3 for itch after the provocation test.
• Cold induced urticaria: Positive ice-cube test resulting in hives at the provocation site during Screening
• Normal blood counts and liver function tests.
• Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
• Willing and able to complete a daily symptom electronic diary and comply with study visits.
• Participants with and without prior biologic experience are eligible. Key
Exclusion Criteria:
• Women who are pregnant or nursing.
• Clearly defined cause for chronic urticaria.
• Active, pruritic skin condition in addition to cold induced urticaria or symptomatic dermographism.
• Medical condition that would cause additional risk or interfere with study procedures.
• Known HIV, hepatitis B or hepatitis C infection.
• Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine.
• History of anaphylaxis, unless due to cold exposure over a large part of the body (such as swimming in cold water).
• Prior treatment with barzolvolimab There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
DRUG: Barzolvolimab, DRUG: Matching Placebo
Chronic Inducible Urticaria, Cold Urticaria, Cold-Induced Urticaria, Symptomatic Dermographism
Chronic Inducible urticaria, cold urticaria, cold-induced urticaria, ColdU, symptomatic dermographism,, SD, barzolvolimab, CDX0159, CDX-0159
Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE2
NCT06931405
Key
Inclusion Criteria:
* Part A: Confirmed diagnosis of CIndU for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines.
* Part B: Confirmed diagnosis of CSU for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines.
Key Exclusion Criteria:
* Part A: Any active urticaria that may interfere with study assessments.
* Part B: Participant has a clearly defined predominant cause of chronic urticaria or sole trigger such as symptomatic dermographism and cold-induced urticaria.
* Part A and Part B: Any other skin disease associated with chronic itching or angioedema that might influence the study evaluations and results, skin diseases associated with only wheals and no itch, or autoinflammatory diseases with urticarial lesions.
* Part A and Part B: Significant medical, psychiatric, or surgical conditions, or physical findings that may affect participant safety, study drug metabolism, study participation, or assessment of study results.
* Part A and Part B: Abnormal laboratory values that may pose risks or interfere with study participation.
* Part A and Part B: Pregnancy or plans for pregnancy; breastfeeding. DRUG: BLU-808, DRUG: Placebo
Chronic Inducible Urticaria, Chronic Spontaneous Urticaria
Chronic Inducible Urticaria, Chronic Spontaneous Urticaria, BLU-808, CIndU, CSU, Chronic Urticaria, CU, Cold Urticaria, ColdU, Symptomatic Dermographism, SD
An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria
clinicaltrials@northshore.org
ALL
18 years to 65 years old
PHASE2
NCT06927999
Inclusion Criteria:
* Is a male or female between the ages of 18 and 65 years, inclusive.
* Has been clinically diagnosed with CSU and experiences an acute flare of moderate to severe urticaria symptoms (itch and hive severity UAS score ≥ 2) approximately 1-2 times a month or every other month consistently during the past year while on a chronic treatment.
* Has been on a daily chronic treatment for ≥ 6 weeks.
* Is willing to use a smartphone study application to record study assessments and AEs.
* Has body weight more than 15 kilogram (kg).
* Has no medical history of clinically significant hypertension and cardiovascular disease in the last 10 years
* If female, is not pregnant or breastfeeding based on a negative urine pregnancy test at baseline.
* Is able to communicate clearly with the Investigator and staff; able to read, complete questionnaires, and perform study procedures on the smartphone study application.
* Is willing and able to provide written informed consent prior to participating in the study.
* Controlled hypertension without beta blocker confirmed by the Investigator is acceptable.
* At screening, has stable vital signs in the following ranges (after 5 minutes of rest):
* Systolic blood pressure (SBP) ≥90 and ≤140 milliliters of mercury (mmHg)
* Diastolic blood pressure (DBP) ≥50 and ≤90 mmHg
* Heart rate (HR) ≥45 and ≤100 beats per minute (bpm)
Exclusion Criteria:
* Has a history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
* Has any clinically significant medical condition or PE finding as deemed inappropriate by the Investigator.
* Has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal electrocardiogram (ECG)
* Has had significant traumatic injury or major surgery within 30 days prior to study screening.
* Known hypersensitivity to any compound in the test product, or any other closely related compound (e.g., dihydropyridine-derived molecules).
* Has participated in a clinical trial within 30 days prior to the first dose of study drug.
* Has an immediate family member of the Investigator, or an employee of the study center, with direct involvement in the proposed study, or other studies under the direction of the Investigator or study center or is in a dependent relationship with a study center employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling), or may consent under duress. DRUG: Placebo, DRUG: 0.5 mg epinephrine, DRUG: 1 mg epinephrine
Urticaria Chronic
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
clinicaltrials@northshore.org
ALL
12 years to 17 years old
PHASE3
NCT05677451
Key
Inclusion Criteria:
* Male and female adolescent participants aged \>= 12 to \< 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 second-generation H1-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 second-generation H1-AH during this time period according to local treatment guidelines
* UAS7 score (range 0 - 42) \>= 16, ISS7 score (range 0 - 21) \>= 6 and HSS7 score (range 0 - 21) \>= 6 during the 7 days prior to randomization (Day 1)
* Documentation of hives within three months before randomization (either at screening and/or at randomization; or documented in the participants' medical history)
Key Exclusion criteria:
* Previous use of remibrutinib or other BTK inhibitors
* Significant bleeding risk or coagulation disorders
* History of gastrointestinal bleeding
* 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
* History or current hepatic disease
* Evidence of clinically significant cardiovascular, 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
* History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes
* Participants having a clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria
* Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary angioedema, or drug-induced urticaria
* 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 or psoriasis
Other protocol-defined inclusion/exclusion criteria may apply. DRUG: LOU064 (blinded), DRUG: placebo
Chronic Spontaneous Urticaria
BTK inhibitor, Chronic spontaneous urticaria, Urticaria activity score, Hives severity score, Itch severity score
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (EMBARQ-CSU1)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT06445023
Key
• Males and females, \>/= 18 years of age.
• Chronic spontaneous urticaria (CSU) \>/= 6 months prior to Screening (Visit 1).
• CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
• The presence of hives for \>/= 6 weeks at any time prior to Visit 1 despite the use of non-sedating H1-antihistamines.
• Must be on a stable regimen of second generation non-sedating H1-antihistamine for \>/= 4 weeks prior to study treatment.
• UAS7 of \>/= 16 and ISS7 of \>/= 8 during the 7 days prior to study treatment.
• Normal blood counts and liver function tests.
• Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
• Willing and able to complete a daily symptom electronic diary and comply with study visits.
• Participants with and without prior biologic experience are eligible. Key
• Women who are pregnant or nursing.
• Chronic urticaria whose predominant manifestation is due to CIndU.
• Other diseases associated with urticaria.
• Active pruritic skin condition in addition to CSU.
• Medical condition that would cause additional risk or interfere with study procedures.
• Known HIV, hepatitis B or hepatitis C infection.
• Vaccination of a live vaccine within 30 days prior to Screening (Visit 1) (subjects must agree to avoid live vaccinations during the study). Inactivated vaccines are allowed such as seasonal influenza injection or authorized COVID-19 vaccine.
• History of anaphylaxis.
• Prior treatment with barzolvolimab. There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Inclusion Criteria:
• Males and females, \>/= 18 years of age.
• Chronic spontaneous urticaria (CSU) \>/= 6 months prior to Screening (Visit 1).
• CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
• The presence of hives for \>/= 6 weeks at any time prior to Visit 1 despite the use of non-sedating H1-antihistamines.
• Must be on a stable regimen of second generation non-sedating H1-antihistamine for \>/= 4 weeks prior to study treatment.
• UAS7 of \>/= 16 and ISS7 of \>/= 8 during the 7 days prior to study treatment.
• Normal blood counts and liver function tests.
• Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
• Willing and able to complete a daily symptom electronic diary and comply with study visits.
• Participants with and without prior biologic experience are eligible. Key
Exclusion Criteria:
• Women who are pregnant or nursing.
• Chronic urticaria whose predominant manifestation is due to CIndU.
• Other diseases associated with urticaria.
• Active pruritic skin condition in addition to CSU.
• Medical condition that would cause additional risk or interfere with study procedures.
• Known HIV, hepatitis B or hepatitis C infection.
• Vaccination of a live vaccine within 30 days prior to Screening (Visit 1) (subjects must agree to avoid live vaccinations during the study). Inactivated vaccines are allowed such as seasonal influenza injection or authorized COVID-19 vaccine.
• History of anaphylaxis.
• Prior treatment with barzolvolimab. There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
BIOLOGICAL: barzolvolimab, BIOLOGICAL: Matching placebo
Chronic Spontaneous Urticaria
CDX-0159, barzolvolimab, chronic spontaneous urticaria, CSU, urticaria activity score, itch severity score, hives severity score
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)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT06868212
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 DRUG: Remibrutinib, DRUG: Remibrutinib matching placebo, DRUG: Dupilumab, DRUG: Placebo solution for injection
Chronic Spontaneous Urticaria (CSU)
BTK inhibitor, chronic spontaneous urticaria, Urticaria activity score, Hives severity score, Itch severity score