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RECRUITING
NCT07456891
PHASE3

Remibrutinib Open Label Roll-over Post-trial Access Protocol

Sponsor: Novartis Pharmaceuticals

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.

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

Interventions

DRUG

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