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An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib
The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 core studies. This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies, where applicable.
Details
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | PHASE3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 696 |
| Start date | Fri Dec 09 2022 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Aug 02 2027 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Chronic Spontaneous Urticaria
Interventions
- LOU064 (blinded)
- Placebo
- LOU064 (open label)
Countries
Italy, Colombia, Japan, Malaysia, Taiwan, Poland, South Korea, Denmark, Russia, Thailand, Bulgaria, Czechia, United States, France, South Africa, Slovakia, Hungary, Argentina, Canada, Puerto Rico, Brazil, Spain, United Kingdom, Germany, Switzerland, Australia, China, Singapore, Turkey (Türkiye), India