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.

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 Overview

• Status: Recruiting
• Conditions: Indication of the Parent Protocol
• Intervention / Treatment: Drug: Remibrutinib

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 212
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6H 5L5
      • Recruiting
      • Novartis Investigative Site
  • Quebec
    • Québec, Quebec, Canada, G1V 4W2
      • Recruiting
      • Novartis Investigative Site
• South Korea
  • Gwangju, South Korea, 61469
    • Recruiting
    • Novartis Investigative Site
  • Seoul, South Korea, 03080
    • Recruiting
    • Novartis Investigative Site
  • Seoul, South Korea, 07441
    • Recruiting
    • Novartis Investigative Site
  • Dalseo Gu
    • Daegu, Dalseo Gu, South Korea, 42602
      • Recruiting
      • Novartis Investigative Site
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, South Korea, 16499
      • Recruiting
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remibrutinib dose level 1; Remibrutinib film coated tablets in the respective dose strength of the parent study	Drug: Remibrutinib; 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	Drug: Remibrutinib; Remibrutinib film coated tablets in the respective dose strength of the parent study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2026
• Primary Completion (Estimated): January 30, 2033
• Study Completion (Estimated): January 30, 2033

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: open label; long-term; Remibrutinib; post-trial access; roll-over
• Additional Relevant MeSH Terms: remibrutinib
• Other Study ID Numbers: CLOU064A2306B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No