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
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
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• 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.
Locations
United States
Arkansas
Johnson Dermatology
RECRUITING
Fort Smith
California
Ctr for Dermatology Clinical Res
RECRUITING
Fremont
USC Keck School of Medicine
RECRUITING
Los Angeles
Olive View UCLA Medical Center
RECRUITING
Sylmar
Clinical Trials Research Institute
RECRUITING
Thousand Oaks
Illinois
Endeavor Health
RECRUITING
Glenview
Dundee Dermatology
RECRUITING
West Dundee
Indiana
Southern IN Clinical Trials
RECRUITING
New Albany
Nebraska
Skin Specialists PC
RECRUITING
Omaha
New York
Cameron Dermatology
RECRUITING
New York
Ohio
Optima Research Boardman
RECRUITING
Boardman
Apex Clinical Research Center LLC
RECRUITING
Mayfield Heights
South Carolina
Clinical Research Ctr of Carolinas
RECRUITING
Charleston
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
RECRUITING
Rosario
Australia
Novartis Investigative Site
RECRUITING
Melbourne
Novartis Investigative Site
RECRUITING
Sydney
Canada
Novartis Investigative Site
RECRUITING
London
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2026-07-10
Estimated Completion Date: 2031-10-24
Participants
Target number of participants: 710
Treatments
Experimental: Remibrutinib Dose A
Participants randomized during the core study to receive remibrutinib Dose A
Experimental: Remibrutinib Dose B
Participants randomized during the core study to receive remibrutinib Dose B
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals