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Study identifier: NCT06868212 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Chronic Spontaneous Urticaria (CSU)  ·  Sponsor: Novartis Pharmaceuticals

PhasePhase 3
Planned participants400
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Novartis Pharmaceuticals  ·  1-888-669-6682  ·  novartis.email@novartis.com

Novartis Pharmaceuticals

Always discuss trial participation with your own doctor first.

Locations (130)

Allervie Clinical ResearchBirmingham, Alabama, United StatesRecruiting
Cahaba Derm and skin hlth ctr 27Birmingham, Alabama, United StatesRecruiting
Research Solutions of ArizonaLitchfield Park, Arizona, United StatesRecruiting
Peak DermatologyPayson, Arizona, United StatesRecruiting
Premier Allergy Asthma And ImmunologyPhoenix, Arizona, United StatesRecruiting
Avacare Center for DermatologyPhoenix, Arizona, United StatesActive Not Recruiting
Orso HealthScottsdale, Arizona, United StatesRecruiting
Clin Trial Inst of Northwest ARFayetteville, Arkansas, United StatesRecruiting
Acuro Research IncLittle Rock, Arkansas, United StatesRecruiting
First OC DermatologyFountain Valley, California, United StatesRecruiting
Ctr for Dermatology Clinical ResFremont, California, United StatesRecruiting
Allergy and Asthma Specialists GroupHuntington Beach, California, United StatesRecruiting

+ 118 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06868212