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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
2031-10-29
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Remibrutinib
Remibrutinib Dose A and B (oral)
Locations (44)
Total Skin and Beauty Dermatology Center PC
Birmingham, Alabama, United States
Johnson Dermatology
Fort Smith, Arkansas, United States
Arkansas Research Trials
North Little Rock, 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
Floridian Research Institute
Miami, Florida, United States
University Of South Florida
Tampa, Florida, 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
Icahn School Of Med At Mount Sinai
New York, New York, United States
OnSite Clinical Solutions LLC
Huntersville, North Carolina, United States
Optima Research Boardman
Boardman, Ohio, United States
Apex Clinical Research Center LLC
Mayfield Heights, Ohio, United States
UP Medical Center H System
Pittsburgh, Pennsylvania, United States
Clinical Research Ctr of Carolinas
Charleston, South Carolina, United States
Center for Clinical Studies-Lee
Webster, Texas, 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
CABA, Argentina
Novartis Investigative Site
Sydney, New South Wales, Australia
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Québec, Quebec, Canada
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Lyon, France
Novartis Investigative Site
Bochum, Germany
Novartis Investigative Site
Muar town, Johor, Malaysia
Novartis Investigative Site
Ipoh, Perak, Malaysia
Novartis Investigative Site
George Town, Pulau Pinang, Malaysia
Novartis Investigative Site
Kota Kinabalu, Sabah, Malaysia
Novartis Investigative Site
Selangor Darul Ehsan, Malaysia
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Las Palmas GC, Spain
Novartis Investigative Site
Madrid, Spain