NCT07456891

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.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 212 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Indication of the Parent Protocol

Interventions

Type	Name	Description
DRUG	Remibrutinib	Remibrutinib film coated tablets in the respective dose strength of the parent study.

Timeline

• Start date: 2026-04-10
• Primary completion: 2033-01-30
• Completion: 2033-01-30
• First posted: 2026-03-09
• Last updated: 2026-03-09

Regulatory

• FDA-regulated drug study