NCT07456891From ClinicalTrials.govRecruiting

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.

Indication of the Parent Protocol

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Novartis Pharmaceuticals
Enrolment target: 648
Started: 16 April 2026
Main results due: 30 January 2033
Study sites: 40
Registry updated: 25 September 2026

Can you take part?

Ages 18 years to 100 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

\- Participant has completed treatment per protocol in a Novartis study of remibrutinib (unless otherwise specified in a parent study protocol) in a dermatological or allergology indication.

Participants, who derive benefit from the treatment with remibrutinib but have not completed the treatment in certain parent studies due to parent study termination by Novartis, may be eligible if the termination was due to reasons other than safety or lack of efficacy (e.g., technical / administrative reasons).

* Participant is deriving benefit from remibrutinib, investigator believes he/she would continue to derive benefit from remibrutinib and the benefit outweighs the risk, based on the investigator's judgement.
* Participant is unable to obtain access to the marketed remibrutinib formulation per local post study drug supply program, prescription and/or reimbursement guidelines.

Exclusion Criteria:

Participants meeting any of the following criteria are not eligible for inclusion in this study.

* Participant has prematurely discontinued study treatment in the parent study.
* Use of prohibited medications

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(40)

Novartis Investigative Site
Sofia, Bulgaria
Recruiting
Novartis Investigative Site
Sofia, Bulgaria
Recruiting
Novartis Investigative Site
Varna, Bulgaria
Recruiting
Novartis Investigative Site
Fredericton, New Brunswick, Canada
Recruiting
Novartis Investigative Site
Hamilton, Ontario, Canada
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Novartis Investigative Site
London, Ontario, Canada
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Novartis Investigative Site
Québec, Quebec, Canada
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Novartis Investigative Site
Verdun, Quebec, Canada
Recruiting
Novartis Investigative Site
Brno, Czechia
Recruiting
Novartis Investigative Site
Plzen Bolevec, Czechia
Recruiting
Novartis Investigative Site
Prague, Czechia
Recruiting
Novartis Investigative Site
Prague, Czechia
Recruiting
Novartis Investigative Site
Bordeaux, France
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Novartis Investigative Site
Brest, France
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Novartis Investigative Site
Montpellier, France
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Novartis Investigative Site
Paris, France
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Novartis Investigative Site
Pierre-Bénite, France
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Novartis Investigative Site
Rouen, France
Recruiting
Novartis Investigative Site
Krosno, Krosno, Poland
Recruiting
Novartis Investigative Site
Poznan, Poland, Poland
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Novartis Investigative Site
Gdansk, Poland
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Novartis Investigative Site
Gdansk, Poland
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Novartis Investigative Site
Poznan, Poland
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Novartis Investigative Site
Daegu, Dalseo gu, South Korea
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Novartis Investigative Site
Hwaseong-si, Gyeonggi-do, South Korea
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Novartis Investigative Site
Suwon, Gyeonggi-do, South Korea
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Novartis Investigative Site
Dongjak Gu, Seoul, South Korea
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Novartis Investigative Site
Seoul, Seoul, South Korea
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Novartis Investigative Site
Gwangju, South Korea
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Novartis Investigative Site
Incheon, South Korea
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Novartis Investigative Site
Seoul, South Korea
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Novartis Investigative Site
Seoul, South Korea
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Novartis Investigative Site
Barcelona, Catalonia, Spain
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Novartis Investigative Site
Alicante, Spain
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Novartis Investigative Site
Barcelona, Spain
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Novartis Investigative Site
Córdoba, Spain
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Novartis Investigative Site
Madrid, Spain
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Novartis Investigative Site
Valencia, Spain
Recruiting
Novartis Investigative Site
Valencia, Spain
Recruiting
Novartis Investigative Site
Hanoi, Vietnam, Vietnam
Recruiting

Showing 40 of 40 sites. 40 of the 40 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07456891. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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