NCT06868212From ClinicalTrials.govRecruiting

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

A US Phase 3b, Multi-center, Randomized, Double-blind, Double-Dummy 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

Chronic Spontaneous Urticaria (CSU)

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Novartis Pharmaceuticals
Enrolment target: 400
Started: 11 July 2025
Main results due: 22 February 2027
Study sites: 132
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(132)

Allervie Clinical Research
Birmingham, Alabama, United States
Active, not recruiting
Cahaba Derm and skin hlth ctr 27
Birmingham, Alabama, United States
Active, not recruiting
Research Solutions of Arizona
Litchfield Park, Arizona, United States
Active, not recruiting
Peak Dermatology
Payson, Arizona, United States
Active, not recruiting
Premier Allergy Asthma And Immunology
Phoenix, Arizona, United States
Active, not recruiting
Avacare Center for Dermatology
Phoenix, Arizona, United States
Withdrawn
Orso Health
Scottsdale, Arizona, United States
Active, not recruiting
Clin Trial Inst of Northwest AR
Fayetteville, Arkansas, United States
Withdrawn
Acuro Research Inc
Little Rock, Arkansas, United States
Active, not recruiting
First OC Dermatology
Fountain Valley, California, United States
Active, not recruiting
Ctr for Dermatology Clinical Res
Fremont, California, United States
Active, not recruiting
Allergy and Asthma Specialists Group
Huntington Beach, California, United States
Active, not recruiting
Orso Health
Long Beach, California, United States
Active, not recruiting
Ark Clinical Research
Long Beach, California, United States
Active, not recruiting
California Allergy and Asthma Medical Group
Los Angeles, California, United States
Active, not recruiting
Dermatology Research Associates
Los Angeles, California, United States
Active, not recruiting
One Of A Kind Clinical Research
Napa, California, United States
Active, not recruiting
Stanford University Medical Center
Palo Alto, California, United States
Recruiting
Empire Clinical Research
Pomona, California, United States
Active, not recruiting
Allergy and Asthma Consultants
Redwood City, California, United States
Active, not recruiting
Norcal Clinical Research
Rocklin, California, United States
Active, not recruiting
Peninsula Research Associates
Rolling Hills Estates, California, United States
Recruiting
Integrative Skin Science and Res
Sacramento, California, United States
Active, not recruiting
UC Davis Neuromuscular Research Center
Sacramento, California, United States
Active, not recruiting
Therapeutics Clinical Research
San Diego, California, United States
Active, not recruiting
Dermatology Institute and Skin Care
Santa Monica, California, United States
Recruiting
Integrated Research of Inland Inc
Upland, California, United States
Active, not recruiting
Allergy and Asthma Clin Res Inc
Walnut Creek, California, United States
Active, not recruiting
University of Colorado Hospital - Aurora
Aurora, Colorado, United States
Active, not recruiting
Asthma and Allergy Associates P C
Colorado Springs, Colorado, United States
Active, not recruiting
Colorado ENT and Allergy
Colorado Springs, Colorado, United States
Recruiting
Skylight Health Res Inc Color Spr
Colorado Springs, Colorado, United States
Withdrawn
UCONN Health Dermatology
Farmington, Connecticut, United States
Withdrawn
Howard University Hospital Division of Geriatrics
Washington D.C., District of Columbia, United States
Active, not recruiting
Florida Ctr Allergy Asthma Research
Aventura, Florida, United States
Active, not recruiting
Skin Care Research Inc
Boca Raton, Florida, United States
Active, not recruiting
Omnicure Clinical Research
Doral, Florida, United States
Active, not recruiting
FXM Clinical Research Ft Laud
Fort Lauderdale, Florida, United States
Active, not recruiting
Skin Care Research LLC
Hollywood, Florida, United States
Active, not recruiting
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Active, not recruiting
University of MiamiHealth System
Miami, Florida, United States
Completed
FXM Clinical Res Miami LLC
Miami, Florida, United States
Active, not recruiting
Miami Dade Medical Research
Miami, Florida, United States
Completed
FXM Clin Res Miramar LLC
Miramar, Florida, United States
Active, not recruiting
Ziaderm Research LLC
North Miami Beach, Florida, United States
Completed
AllerVie Health
Panama, Florida, United States
Active, not recruiting
Sarasota Clinical Research
Sarasota, Florida, United States
Active, not recruiting
Lenus Research and Med Group LLC
Sweetwater, Florida, United States
Active, not recruiting
Olympian Clinical Research
Tampa, Florida, United States
Withdrawn
Asthma Allergy Immunology Clin Res
Tampa, Florida, United States
Active, not recruiting
Conquest Research
Winter Park, Florida, United States
Active, not recruiting
AllerVie Clin Res Columbus GA
Columbus, Georgia, United States
Active, not recruiting
Cleaver Medical Group
Cumming, Georgia, United States
Active, not recruiting
Southeast Dermatology Specialists
Douglasville, Georgia, United States
Active, not recruiting
Aeroallergy Research Laboratories
Savannah, Georgia, United States
Active, not recruiting
The Allergy Group-Meridian Clinic
Meridian, Idaho, United States
Active, not recruiting
NW Uni C and T Sciences Ins
Chicago, Illinois, United States
Completed
Rush University Medical Center
Chicago, Illinois, United States
Active, not recruiting
Midwest Allergy Sinus Asthma SC
Normal, Illinois, United States
Active, not recruiting
Clinical Res Ctr of S Illinois
O'Fallon, Illinois, United States
Active, not recruiting

Showing 60 of 132 sites — filter to narrow it down. 9 of the 132 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06868212. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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