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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Chronic Spontaneous Urticaria (CSU)

In brief

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.

Key facts

Study ID: NCT06868212
Run by: Novartis Pharmaceuticals
People needed: 400
Starts: 2025-07-11
Expected to finish: 2027-05-17
Last updated by the study team: 2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

Cahaba Derm and skin hlth ctr 27 — Birmingham, Alabama, United States (enrolling)
Allervie Clinical Research — Birmingham, Alabama, United States (enrolling)
Peak Dermatology — Payson, Arizona, United States (enrolling)
Premier Allergy Asthma And Immunology — Phoenix, Arizona, United States (enrolling)
Research Solutions of Arizona — Litchfield Park, Arizona, United States (enrolling)
Orso Health — Scottsdale, Arizona, United States (enrolling)
Clin Trial Inst of Northwest AR — Fayetteville, Arkansas, United States (enrolling)
Acuro Research Inc — Little Rock, Arkansas, United States (enrolling)
First OC Dermatology — Fountain Valley, California, United States (enrolling)
Ctr for Dermatology Clinical Res — Fremont, California, United States (enrolling)
Allergy and Asthma Specialists Group — Huntington Beach, California, United States (enrolling)
Orso Health — Long Beach, California, United States (enrolling)
Ark Clinical Research — Long Beach, California, United States (enrolling)
California Allergy and Asthma Medical Group — Los Angeles, California, United States (enrolling)
Dermatology Research Associates — Los Angeles, California, United States (enrolling)
One Of A Kind Clinical Research — Napa, California, United States (enrolling)
Empire Clinical Research — Pomona, California, United States (enrolling)
Allergy and Asthma Consultants — Redwood City, California, United States (enrolling)
Norcal Clinical Research — Rocklin, California, United States (enrolling)
Peninsula Research Associates — Rolling Hills Estates, California, United States (enrolling)
Integrative Skin Science and Res — Sacramento, California, United States (enrolling)
UC Davis Neuromuscular Research Center — Sacramento, California, United States (enrolling)
Therapeutics Clinical Research — San Diego, California, United States (enrolling)
Dermatology Institute and Skin Care — Santa Monica, California, United States (enrolling)
Integrated Research of Inland Inc — Upland, California, United States (enrolling)

Full record on ClinicalTrials.gov

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