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 (NCT06868212)
🩺 Plain-English Summary (8th-Grade Level)
This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily \[b.i.d.\] by mouth \[p.o.\]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (9 items).
Location: Allervie Clinical Research — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (133 Sites)
- Allervie Clinical Research — Birmingham, Alabama
- Cahaba Derm and skin hlth ctr 27 — Birmingham, Alabama
- Research Solutions of Arizona — Litchfield Park, Arizona
- Peak Dermatology — Payson, Arizona
- Premier Allergy Asthma And Immunology — Phoenix, Arizona
- Avacare Center for Dermatology — Phoenix, Arizona
- Orso Health — Scottsdale, Arizona
- Clin Trial Inst of Northwest AR — Fayetteville, Arkansas
- Acuro Research Inc — Little Rock, Arkansas
- First OC Dermatology — Fountain Valley, California
- Ctr for Dermatology Clinical Res — Fremont, California
- Allergy and Asthma Specialists Group — Huntington Beach, California
- Orso Health — Long Beach, California
- Ark Clinical Research — Long Beach, California
- California Allergy and Asthma Medical Group — Los Angeles, California
- Dermatology Research Associates — Los Angeles, California
- One Of A Kind Clinical Research — Napa, California
- Stanford University Medical Center — Palo Alto, California
- Empire Clinical Research — Pomona, California
- Allergy and Asthma Consultants — Redwood City, California
- Norcal Clinical Research — Rocklin, California
- Peninsula Research Associates — Rolling Hills Estates, California
- Integrative Skin Science and Res — Sacramento, California
- UC Davis Neuromuscular Research Center — Sacramento, California
- Therapeutics Clinical Research — San Diego, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.