A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1-antihistamines
Completed · Phase 3 · Has a placebo group
Conditions studied: Chronic Spontaneous Urticaria
In brief
The purpose of this study was to establish the efficacy, safety, and tolerability of Remibrutinib 25 mg b.i.d. in adult patients suffering from chronic spontaneous urticaria (CSU) inadequately controlled by second generation H1-antihistamines (H1-AHs) in comparison to placebo.
Key facts
- Study ID
- NCT05032157
- Run by
- Novartis Pharmaceuticals
- People needed
- 455
- Starts
- 2021-12-01
- Expected to finish
- 2024-01-05
- Last updated by the study team
- 2025-04-08
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Research Solutions of Arizona — Litchfield Park, Arizona, United States
- Little Rock Allergy and Asthma Clnc — Little Rock, Arkansas, United States
- Allergy and Asthma Medical Group and Research Center — San Diego, California, United States
- UCONN Health Dermatology — Farmington, Connecticut, United States
- Miami Dade Medical Research — Miami, Florida, United States
- Ziaderm Research LLC — North Miami Beach, Florida, United States
- Riverchase Dermatology — Pembroke Pines, Florida, United States
- TrueBlue Clinical Research — Tampa, Florida, United States
- AeroAllergy Research Laboratories of Savannah Inc — Savannah, Georgia, United States
- Treasure Valley Medical Research — Boise, Idaho, United States
- Northshore University Health System — Glenview, Illinois, United States
- Asthma and Allergy Center of Chicago S C — River Forest, Illinois, United States
- The Indiana Clinical Trials Center — Plainfield, Indiana, United States
- Allergy and Asthma Specialist P S C — Owensboro, Kentucky, United States
- John Hopkins University — Baltimore, Maryland, United States
- Chesapeake Clinical Research — White Marsh, Maryland, United States
- Revival Research Institute — Troy, Michigan, United States
- Montana Medical Research — Missoula, Montana, United States
- Allergy Asthma Assoc Monmouth — Little Silver, New Jersey, United States
- Peters Medical Research — High Point, North Carolina, United States
- CR Services Acquisition US — Dublin, Ohio, United States
- Ohio Clinical Research Associates — Mayfield Heights, Ohio, United States
- Allergy Asthma and Clinical Research — Oklahoma City, Oklahoma, United States
- Allergy and Clinical Immunology Associates — Pittsburgh, Pennsylvania, United States
- Cahaba Derm and skin hlth ctr 27 — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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