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Promising drug remibrutinib gets extended safety check in 648 patients

NCT ID NCT07456891

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 7 times

Summary

This study offers continued treatment with remibrutinib for up to 3 years to people who have already benefited from it in earlier Novartis trials. It aims to collect long-term safety data. About 648 participants with skin or allergy conditions will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Remibrutinib (a drug taken as a tablet)
What this could lead to
If successful, this study could show that remibrutinib is safe and effective for long-term use in skin or allergy conditions.
What could go wrong
This is an open-label roll-over study, not a placebo-controlled trial, so results may be less definitive. Side effects could emerge with longer use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 648 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jan 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Indication of the parent protocol

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    39 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Novartis Investigative Site

    RECRUITING

    Sofia, 1421, Bulgaria

  • Novartis Investigative Site

    RECRUITING

    Sofia, 1431, Bulgaria

  • Novartis Investigative Site

    RECRUITING

    Varna, 9009, Bulgaria

  • Novartis Investigative Site

    RECRUITING

    Hamilton, Ontario, L8L 3C3, Canada

  • Novartis Investigative Site

    RECRUITING

    London, Ontario, N6H 5L5, Canada

  • Novartis Investigative Site

    RECRUITING

    Québec, Quebec, G1V 4W2, Canada

  • Novartis Investigative Site

    RECRUITING

    Verdun, Quebec, H4G 3E7, Canada

  • Novartis Investigative Site

    RECRUITING

    Brno, 602 00, Czechia

  • Novartis Investigative Site

    RECRUITING

    Plzen Bolevec, 32300, Czechia

  • Novartis Investigative Site

    RECRUITING

    Prague, 100 34, Czechia

  • Novartis Investigative Site

    RECRUITING

    Prague, 150 06, Czechia

  • Novartis Investigative Site

    RECRUITING

    Bordeaux, 33075, France

  • Novartis Investigative Site

    RECRUITING

    Brest, 29609, France

  • Novartis Investigative Site

    RECRUITING

    Montpellier, 34295, France

  • Novartis Investigative Site

    RECRUITING

    Paris, 75970, France

  • Novartis Investigative Site

    RECRUITING

    Pierre-Bénite, 69495, France

  • Novartis Investigative Site

    RECRUITING

    Rouen, 76031, France

  • Novartis Investigative Site

    RECRUITING

    Krosno, Krosno, 38-400, Poland

  • Novartis Investigative Site

    RECRUITING

    Poznan, Poland, 60-693, Poland

  • Novartis Investigative Site

    RECRUITING

    Gdansk, 80-214, Poland

  • Novartis Investigative Site

    RECRUITING

    Gdansk, 80-546, Poland

  • Novartis Investigative Site

    RECRUITING

    Poznan, 60-823, Poland

  • Novartis Investigative Site

    RECRUITING

    Daegu, Dalseo gu, 42602, South Korea

  • Novartis Investigative Site

    RECRUITING

    Hwaseong-si, Gyeonggi-do, 18450, South Korea

  • Novartis Investigative Site

    RECRUITING

    Suwon, Gyeonggi-do, 16499, South Korea

  • Novartis Investigative Site

    RECRUITING

    Dongjak Gu, Seoul, 07061, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, Seoul, 03080, South Korea

  • Novartis Investigative Site

    RECRUITING

    Gwangju, 61469, South Korea

  • Novartis Investigative Site

    RECRUITING

    Incheon, 21565, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 07441, South Korea

  • Novartis Investigative Site

    RECRUITING

    Barcelona, Catalonia, 08003, Spain

  • Novartis Investigative Site

    RECRUITING

    Alicante, 03010, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    RECRUITING

    Córdoba, 14004, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28027, Spain

  • Novartis Investigative Site

    RECRUITING

    Valencia, 46015, Spain

  • Novartis Investigative Site

    RECRUITING

    Valencia, 46026, Spain

  • Novartis Investigative Site

    RECRUITING

    Hanoi, Vietnam, 100000, Vietnam