An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
This is a global Phase 3, multicentre, double‐blind, double‐dummy, parallel‐groupextension study. It fulfils the Novartis commitment to provide post‐trial access.The study includes a double‐blind and an open‐label treatment phase:Double‐blind, double‐dummy treatment continues from Week 68 (end of core study) untilfinal database lock (DBL) of both core studies or until up titration. Participants remainon the same blinded regimen they were on during Treatment Period 2 of the preceding Phase3 studies.After final DBL of both core studies, treatment transitions to open‐label.Participants will continue treatment until commercial availability and reimbursement intheir country, another access mechanism is available, or 4 years of extension treatmentis completed.Participants who discontinue treatment early or do not transition to commercialremibrutinib will enter a 4‐week treatment‐free safety follow‐up.
Epistemonikos ID: b075ad8d317feaf4ec88f06b5a3000f366c91596
First added on: Jun 25, 2026