Available in Argentina, United States
This study consists of a core and extension periods.
The Core period (6 arms) has a total duration of up to 60 weeks including a double-blind
placebo-controlled treatment period until Week 24 followed by open-label treatment with
remibrutinib up to Week 52. The primary endpoint for all CINDU subtypes is assessed at
Week 12.
The Core period consists of:
- Screening period (up to 4 weeks): During the screening period, participants who have
provided informed consent will be assessed for study eligibility.
- Double-blind, placebo-controlled treatment period (24 weeks): 24 weeks of
double-blind treatment with remibrutinib or placebo.
- Open-label treatment period (28 weeks): 28 weeks of open-label treatment with
remibrutinib.
- Follow-up period: 4 weeks of treatment free follow-up. The open-label extension
period consists of observation and treatment period. At the end of the core period
of the study, if participants continue to experience symptoms, they will transition
to the treatment period in OLE. If they do not experience symtpoms they will
transition to the observation period in the OLE.
The duration of the Open-label Extension period will be approximately 3 years where
participants can switch from observation to treatment depending on if they start
developing symptoms. Only those participants participating in the Open-label Extension
Treatment period will receive remibrutinib. The participants in the Open-label Extension
Observation period will not receive remibrutinib
5Research sites
348Patients around the world