Open-label roll-over access to remibrutinib
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.
This program continues remibrutinib treatment and monitors long-term safety for people who were already benefiting from remibrutinib in a Novartis study but cannot get it outside the study.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Drugs / interventions | remibrutinib |
| Locations | 3 sites (London, Ontario and 2 other locations) |
| Trial ID | NCT07456891 on ClinicalTrials.gov |
What this trial studies
This multi-center, open-label roll-over protocol provides continued remibrutinib to eligible participants who completed or were benefiting from a Novartis remibrutinib study and lack outside access. There is no screening period and participants may start treatment after consent and an enrollment visit that confirms eligibility. Participants receive the same remibrutinib dose and regimen they last had in the parent study and return to the site at least every 16 weeks for medication resupply and safety monitoring. Treatment continues for up to three years or until prespecified stopping reasons such as loss of benefit, pregnancy, withdrawal of consent, protocol non-compliance, investigator decision, or access to remibrutinib outside the program.
Who should consider this trial
Good fit: Ideal candidates are participants who completed (or were deriving benefit from) a Novartis remibrutinib dermatology or allergology parent study, are judged by the investigator to still benefit, and cannot access remibrutinib outside a study.
Not a fit: Patients not deriving benefit, those who can obtain remibrutinib commercially or via local supply programs, pregnant individuals, or those with safety concerns or protocol non-compliance are unlikely to benefit from joining.
Why it matters
Potential benefit: If successful, the program would allow patients who benefit from remibrutinib to maintain therapy and generate up to three years of safety data to inform future use.
How similar studies have performed: Open-label roll-over and post-trial access programs are commonly used to provide continued treatment and collect long-term safety data for other therapies, though remibrutinib-specific long-term outcomes remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London, Ontario and 2 other locations
- Novartis Investigative Site — London, Ontario, Canada (Recruiting)
- Novartis Investigative Site — Daegu, Dalseo Gu, South Korea (Recruiting)
- Novartis Investigative Site — Gwangju, South Korea (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.