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An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS
Sponsor: Novartis Pharmaceuticals
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
710
Start Date
2026-07-10
Completion Date
2031-10-24
Last Updated
2026-09-14
Healthy Volunteers
No
Conditions
Interventions
Remibrutinib
Remibrutinib Dose A and B (oral)
Locations (20)
Johnson Dermatology
Fort Smith, Arkansas, United States
Ctr for Dermatology Clinical Res
Fremont, California, United States
USC Keck School of Medicine
Los Angeles, California, United States
Olive View UCLA Medical Center
Sylmar, California, United States
Clinical Trials Research Institute
Thousand Oaks, California, United States
Endeavor Health
Glenview, Illinois, United States
Dundee Dermatology
West Dundee, Illinois, United States
Southern IN Clinical Trials
New Albany, Indiana, United States
Skin Specialists PC
Omaha, Nebraska, United States
Cameron Dermatology
New York, New York, United States
Optima Research Boardman
Boardman, Ohio, United States
Apex Clinical Research Center LLC
Mayfield Heights, Ohio, United States
Clinical Research Ctr of Carolinas
Charleston, South Carolina, United States
Novartis Investigative Site
Caba, Buenos Aires, Argentina
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina
Novartis Investigative Site
CABA, Argentina
Novartis Investigative Site
Sydney, New South Wales, Australia
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
London, Ontario, Canada