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
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.
| Facility | City | Region | Status |
|---|---|---|---|
| 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| Avacare Center for Dermatology | Phoenix | Arizona | Withdrawn |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.
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