A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Chronic Inducible Urticaria
In brief
This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE). The purpose of the core period (52 weeks of treatment) of this study is to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults suffering from CINDU inadequately controlled by H1-antihistamines (H1-AHs). The purpose of the OLE period is to collect long-term efficacy, safety, and tolerability data on remibrutinib in participants after having completed the Core period
Key facts
- Study ID
- NCT05976243
- Run by
- Novartis Pharmaceuticals
- People needed
- 362
- Starts
- 2023-12-07
- Expected to finish
- 2029-06-15
- Last updated by the study team
- 2026-06-08
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Novartis Investigative Site — Rosario, Santa Fe Province, Argentina
- Novartis Investigative Site — CABA, Argentina
- Novartis Investigative Site — Woolloongabba, Queensland, Australia
- Novartis Investigative Site — Carlton, Victoria, Australia
- Novartis Investigative Site — Melbourne, Victoria, Australia
- Novartis Investigative Site — Alphaville Barueri, São Paulo, Brazil
- Allervie Clinical Research — Birmingham, Alabama, United States
- Acuro Research Inc — Little Rock, Arkansas, United States
- Kern Research — Bakersfield, California, United States
- Allergy and Asthma Specialists Group — Huntington Beach, California, United States
- Antelope Valley Clinical Trials — Lancaster, California, United States
- Asthma and Allergy Associates P C — Colorado Springs, Colorado, United States
- Florida Ctr Allergy Asthma Research — Aventura, Florida, United States
- Sarasota Clinical Research — Sarasota, Florida, United States
- Univ of South Florida Asthma Allergy and Immunology CRU — Tampa, Florida, United States
- Aeroallergy Research Laboratories — Savannah, Georgia, United States
- Treasure Valley Medical Research — Boise, Idaho, United States
- Endeavor Health — 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
- Allergy Asthma and Clinical Research — Oklahoma City, Oklahoma, United States
- Allergy and Clinical Immunology Associates — Pittsburgh, Pennsylvania, United States
- Novartis Investigative Site — CABA, Buenos Aires, Argentina
Full record on ClinicalTrials.gov
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