Open-Label Multi-Center Study Offering Continued Remibrutinib Treatment for Adults Previously in Novartis Clinical Trials

What this Trial Is About

This research is an open-label, multi-center study designed for adults who have previously participated in Novartis clinical trials involving remibrutinib treatment for dermatological or allergology conditions. It aims to provide continued access to remibrutinib for participants benefiting from the drug and to collect long-term safety data over up to three years. Participants will continue receiving remibrutinib tablets at the same dose and regimen they had in their prior study. There is no screening period after consent and eligibility confirmation at the enrollment visit, participants begin treatment immediately. They will return to the study center at least every 16 weeks for medication resupply but can visit earlier if needed. Treatment continues up to three years or until specific stopping criteria are met, such as loss of benefit or withdrawal. Throughout the study, participants will have regular visits to monitor safety, including tracking of adverse events. Researchers will assess the number of participants experiencing adverse events or serious adverse events over approximately seven years. The study ensures ongoing evaluation of participant well-being and allows for withdrawal at any time, with no cost for study-related care.

Remibrutinib Open Label Roll-over Post-trial Access Protocol