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Recruiting

NCT Number: NCT07456891

Remibrutinib Open Label Roll-over Post-trial Access Protocol

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.

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Sofia, Bulgaria

Loading trial locations.

About this study

There will be no screening period for this study. After completion of the appropriate consent process, eligible participants can start treatment with remibrutinib as soon as they enter the study. All participants must visit the study site for their enrollment visit to confirm eligibility and commence study participation. Participants will return to the study center at least every 16 weeks for resupply of study medication but may return earlier if needed.

Participants will receive remibrutinib at the dose and regimen they last received in the parent study.

Participants will continue to receive remibrutinib for up to 3 years or until one of the following occurs: no treatment benefit, participant wishes to discontinue trial participation or withdraws consent, protocol non-compliance, pregnancy, the investigator feels it is no longer in the participant's best interest to continue therapy, or the participant receives access to treatment with remibrutinib outside of a clinical study, whichever occurs first.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remibrutinib

Drug

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

Primary outcomes

  1. Number of participants with the occurrence of AEs or SAEs

    Time frame: throughout the study, approximately 7 years

    Number of participants with the occurrence of AEs or SAEs

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Mar 9, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.