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Remibrutinib Open Label Roll-over Post-trial Access Protocol
Sponsor: Novartis Pharmaceuticals
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.
Official title: An Open-label, Multi-center Protocol for Patients Who Have Completed a Previous Novartis Sponsored Remibrutinib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Remibrutinib.
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
212
Start Date
2026-04-16
Completion Date
2033-01-30
Last Updated
2026-05-27
Healthy Volunteers
No
Conditions
Interventions
Remibrutinib
Remibrutinib film coated tablets in the respective dose strength of the parent study.
Locations (6)
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
Daegu, Dalseo Gu, South Korea
Novartis Investigative Site
Suwon, Gyeonggi-do, South Korea
Novartis Investigative Site
Gwangju, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea