An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS
NCT07665437 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 710
Last updated 2026-08-18
Summary
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.
Conditions
Interventions
- DRUG
-
Remibrutinib Dose A and B (oral)
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-10
- Primary Completion
- 2031-10-27
- Completion
- 2031-10-27
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Canada
Study Locations
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