Remibrutinib Open Label Roll-over Post-trial Access Protocol

NCT07456891 | Recruiting Phase 3 FDA Drug

• 1 other identifier: CLOU064A2306B
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with the occurrence of AEs or SAEs

  Number of participants with the occurrence of AEs or SAEs

  throughout the study, approximately 7 years

Study Arms (2)

Remibrutinib dose level 1

EXPERIMENTAL

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

Drug: Remibrutinib

Remibrutinib dose level 2

EXPERIMENTAL

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

Drug: Remibrutinib

Interventions

Remibrutinib DRUG

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

Remibrutinib dose level 1; Remibrutinib dose level 2

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

London, Ontario, N6H 5L5, Canada

RECRUITING

MeSH Terms

Interventions

remibrutinib

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 9, 2026
• Study Start: April 16, 2026
• Primary Completion (Estimated): January 30, 2033
• Study Completion (Estimated): January 30, 2033
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)