RecruitingPhase 3NCT07456891

Remibrutinib Open Label Roll-over Post-trial Access Protocol

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.


Sponsor

Novartis Pharmaceuticals

Enrollment

648 participants

Start Date

Apr 16, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Remibrutinib for people with indication of the parent protocol. The study is currently recruiting participants at 33 locations. People eligible for this study include aged 18 Years to 100 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRemibrutinib

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

View Full Details on ClinicalTrials.gov

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NCT07456891