Open-label roll-over access to remibrutinib

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Other protocol-defined inclusion/exclusion criteria may apply.

Where it's running

• Novartis Investigative Site
  Sofia, Bulgaria Recruiting
• Novartis Investigative Site
  Sofia, Bulgaria Recruiting
• Novartis Investigative Site
  Varna, Bulgaria Recruiting
• Novartis Investigative Site
  Fredericton, New Brunswick, Canada Recruiting
• Novartis Investigative Site
  Hamilton, Ontario, Canada Recruiting
• Novartis Investigative Site
  London, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.