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Clinical Trials in the USA / NCT06868212
Recruiting Phase 3

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 · tracked via the Priya Life Science USA tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2025-07-11
Last updated
2026-08-19

Condition(s) studied

Chronic Spontaneous Urticaria (CSU)

Investigational drug(s) / intervention(s)

RemibrutinibRemibrutinib matching placeboDupilumabPlacebo solution for injection

Remibrutinib: Film-coated tablet, oral administration, 25 mg b.i.d.

Remibrutinib matching placebo: Film-coated tablet, oral administration, b.i.d.

Dupilumab: Solution for injection in pre-filled syringe 600 mg loading dose followed by 300 mg dose every 2 weeks

Placebo solution for injection: Solution for injection in pre-filled syringe every 2 weeks

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (133)

FacilityCityRegionStatus
Allervie Clinical Research Birmingham Alabama Recruiting
Cahaba Derm and skin hlth ctr 27 Birmingham Alabama Recruiting
Research Solutions of Arizona Litchfield Park Arizona Recruiting
Peak Dermatology Payson Arizona Recruiting
Premier Allergy Asthma And Immunology Phoenix Arizona Recruiting
Avacare Center for Dermatology Phoenix Arizona Withdrawn
Orso Health Scottsdale Arizona Recruiting
Clin Trial Inst of Northwest AR Fayetteville Arkansas Recruiting
Acuro Research Inc Little Rock Arkansas Recruiting
First OC Dermatology Fountain Valley California Recruiting
Ctr for Dermatology Clinical Res Fremont California Recruiting
Allergy and Asthma Specialists Group Huntington Beach California Recruiting
Orso Health Long Beach California Recruiting
Ark Clinical Research Long Beach California Recruiting
California Allergy and Asthma Medical Group Los Angeles California Recruiting
Dermatology Research Associates Los Angeles California Recruiting
One Of A Kind Clinical Research Napa California Recruiting
Stanford University Medical Center Palo Alto California Recruiting
Empire Clinical Research Pomona California Recruiting
Allergy and Asthma Consultants Redwood City California Recruiting
Norcal Clinical Research Rocklin California Recruiting
Peninsula Research Associates Rolling Hills Estates California Recruiting
Integrative Skin Science and Res Sacramento California Recruiting
UC Davis Neuromuscular Research Center Sacramento California Recruiting
Therapeutics Clinical Research San Diego California Recruiting
Dermatology Institute and Skin Care Santa Monica California Recruiting
Integrated Research of Inland Inc Upland California Recruiting
Allergy and Asthma Clin Res Inc Walnut Creek California Recruiting
University of Colorado Hospital - Aurora Aurora Colorado Recruiting
Asthma and Allergy Associates P C Colorado Springs Colorado Recruiting
Colorado ENT and Allergy Colorado Springs Colorado Recruiting
Skylight Health Res Inc Color Spr Colorado Springs Colorado Recruiting
UCONN Health Dermatology Farmington Connecticut Recruiting
Howard University Hospital Division of Geriatrics Washington D.C. District of Columbia Recruiting
Florida Ctr Allergy Asthma Research Aventura Florida Recruiting
Florida Ctr Allergy Asthma Research Aventura Florida Recruiting
Skin Care Research Inc Boca Raton Florida Recruiting
Omnicure Clinical Research Doral Florida Recruiting
FXM Clinical Research Ft Laud Fort Lauderdale Florida Recruiting
Skin Care Research LLC Hollywood Florida Recruiting

+ 93 more sites — see the full list on the official registry below.

On this site

📄 Dupixent (dupilumab) drug profile →

More Novartis Pharmaceuticals trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06868212 on ClinicalTrials.gov ↗ ← All trials in the USA