Clinical Trial

Remibrutinib Open Label Roll-over Post-trial Access Protocol

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
Multi-center, open-label roll-over post-trial access protocol to provide remibrutinib treatment and collect long-term safety for up to three years for participants who are currently receiving remibrutinib treatment in a Novartis-sponsored study, who are benefiting from treatment with remibrutinib, and are unable to access remibrutinib treatment outside of a clinical study.
Protocol Amendment History 5 changes
notable Trial sites expanded: 26 -> 33 locations 2026-07-09
notable Enrollment increased: 212 -> 648 participants 2026-06-27
notable Trial sites expanded: 13 -> 26 locations 2026-06-27
notable Trial sites expanded: 7 -> 13 locations 2026-06-19
critical Recruitment opened 2026-05-07
Trial Details
NCT Number NCT07456891
Lead Sponsor Novartis Pharmaceuticals
Conditions Indication of the Parent Protocol
Enrollment 648 participants
Start Date 2026-04-16
Primary Completion 2033-01-30 (estimated)
Study Completion 2033-01-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-08