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An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS
A Double-blind, Double-dummy, Parallel Group, Multicenter Phase 3 Extension Study Evaluating the Long-term Safety and Efficacy of 2 Doses of Remibrutinib in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Who can join
Ages 18 to 100 · All sexes
Full eligibility criteria
Key Inclusion Criteria: * Signed informed consent must be obtained before any assessment is performed. * Participant has completed the full study treatment period according to the protocol (68 weeks) in the core studies (CLOU064J12301 or CLOU064J12302). * Participant does not meet any treatment discontinuation criteria of the core study at Week 68. Key Exclusion Criteria: * Ongoing or planned use of prohibited HS or non-HS treatments. * Participants not expected to benefit from participation in the extension study or participants expected to be exposed to an undue safety risk if participating in the extension study, as assessed by the Investigator. * Current severe progressive or uncontrolled disease, which in the judgment of the Investigator renders the participant unsuitable for the study. Other protocol-defined inclusion/exclusion criteria may apply.
About the study
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of remibrutinib (LOU064) in adult participants with moderate to severe hidradenitis suppurativa (HS) who have completed either of the preceding Phase 3 studies, CLOU064J12301 or CLOU064J12302.
What is being tested
- Remibrutinib (drug)
Sponsor: Novartis Pharmaceuticals · Participants: 710 · Started: Jul 10, 2026
Contact the study team
- Novartis Pharmaceuticals · Phone: 1-888-669-6682
- Novartis Pharmaceuticals · Phone: +41613241111
Official record on ClinicalTrials.gov — NCT07665437
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.