An extension study of long-term efficacy and safety of remibrutinib in the treatment of chronic spontaneous urticaria participants who completed studies with remibrutinib
Phase 3
- Conditions
- Health Condition 1: L508- Other urticaria
- Registration Number
- CTRI/2024/01/061150
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Written informed consent must be obtained before any assessment is performed.
Male and female, adult participants =18 years of age.
Participants who successfully completed the preceding core studies CLOU064A2301, CLOU064A2302, CLOU064A1301, CLOU064A2304 or CLOU064A2305 according to the respective protocols.
Willing and able to adhere to the study protocol and visit schedule.
Exclusion Criteria
Significant bleeding risk or coagulation disorders.
History of gastrointestinal bleeding.
Requirement for anti-platelet medication.
Requirement for anticoagulant medication.
History or current hepatic disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the efficacy of remibrutinib in CSU participants with a UAS7 (Weekly Urticaria Activity Score)16 at Week 52 in the prior core study with respect to time to first of the three events: relapse or study treatment discontinuation due to lack of efficacy or intake of strongly confounding prohibited medication up to Week 24 compared to placebo.Timepoint: relapse, defined as UAS7=16 up to Week 24
- Secondary Outcome Measures
Name Time Method To assess the long-term safety & tolerability of remibrutinibTimepoint: every 12 week