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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

648

Start Date

2026-04-16

Completion Date

2033-01-30

Last Updated

2026-07-08

Healthy Volunteers

No

Interventions

DRUG

Remibrutinib

Remibrutinib film coated tablets in the respective dose strength of the parent study.

Locations (33)

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Varna, Bulgaria

Novartis Investigative Site

Hamilton, Ontario, Canada

Novartis Investigative Site

London, Ontario, Canada

Novartis Investigative Site

Québec, Quebec, Canada

Novartis Investigative Site

Verdun, Quebec, Canada

Novartis Investigative Site

Brno, Czechia

Novartis Investigative Site

Plzen Bolevec, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Bordeaux, France

Novartis Investigative Site

Brest, France

Novartis Investigative Site

Montpellier, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Rouen, France

Novartis Investigative Site

Gdansk, Poland

Novartis Investigative Site

Gdansk, Poland

Novartis Investigative Site

Krosno, Poland

Novartis Investigative Site

Poznan, Poland

Novartis Investigative Site

Poznan, Poland

Novartis Investigative Site

Daegu, Dalseo Gu, South Korea

Novartis Investigative Site

Suwon, Gyeonggi-do, South Korea

Novartis Investigative Site

Dongjak Gu, Seoul, South Korea

Novartis Investigative Site

Gwangju, South Korea

Novartis Investigative Site

Incheon, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Alicante, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Valencia, Spain

Novartis Investigative Site

Valencia, Spain