Recruiting
Phase 3

Remibrutinib

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07456891

Conditions

Indication of the Parent Protocol

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Remibrutinib

Study Details

Brief 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.

Conditions

Indication of the Parent Protocol

Study ID

NCT07456891

Start date

Apr 16, 2026

Status verified date

Sep, 2026

Completion date

Jan 30, 2033

Anticipated

Primary completion date

Jan 30, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

648 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Remibrutinib dose level 1

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

experimental: Remibrutinib dose level 2

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

Interventions

Remibrutinib

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

Primary outcome measure

  • Number of participants with the occurrence of AEs or SAEs [ Time Frame: throughout the study, approximately 7 years ]

Central Contacts and Locations

Central contacts

Locations

Novartis Investigative Site

Recruiting

Hamilton, Ontario, Canada, L8L 3C3

Novartis Investigative Site

Recruiting

London, Ontario, Canada, N6H 5L5

Novartis Investigative Site

Recruiting

Québec, Quebec, Canada, G1V 4W2

Novartis Investigative Site

Recruiting

Verdun, Quebec, Canada, H4G 3E7

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • Remibrutinib
  • long-term
  • roll-over
  • open label
  • post-trial access

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-09-09.