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
3 other identifiers
interventional
710
7 countries
34
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2026
Longer than P75 for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2026
CompletedFirst Posted
Study publicly available on registry
June 24, 2026
CompletedStudy Start
First participant enrolled
July 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 24, 2031
September 28, 2026
September 1, 2026
5.3 years
June 18, 2026
September 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Evaluate the safety of long-term treatment with remibrutinib in adult participants with moderate to severe Hidradenitis Suppurativa.
Baseline, up to Week 280
Secondary Outcomes (4)
Proportion of participants with AN50/75/90 response
Baseline, up to Week 276
Mean Percentage change from baseline in International Hidradenitis Suppurativa severity score system (IHS4)
Baseline, up to Week 276
Proportion of participants with Hidradenitis suppurativa clinical response (HiSCR)50/75/90 response
Baseline, up to Week 276
Proportion of participants with clinical response in HS-related skin pain (numerical rating scale [NRS] 30), at worst
Baseline, up to Week 276
Study Arms (2)
Remibrutinib Dose A
EXPERIMENTALParticipants randomized during the core study to receive remibrutinib Dose A
Remibrutinib Dose B
EXPERIMENTALParticipants randomized during the core study to receive remibrutinib Dose B
Interventions
Remibrutinib Dose A and B (oral)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Johnson Dermatology
Fort Smith, Arkansas, 72916, United States
Ctr for Dermatology Clinical Res
Fremont, California, 95438, United States
USC Keck School of Medicine
Los Angeles, California, 90033, United States
Olive View UCLA Medical Center
Sylmar, California, 91342, United States
Clinical Trials Research Institute
Thousand Oaks, California, 91320, United States
Floridian Research Institute
Miami, Florida, 33179, United States
University Of South Florida
Tampa, Florida, 33612, United States
Endeavor Health
Glenview, Illinois, 60077, United States
Dundee Dermatology
West Dundee, Illinois, 60118, United States
Southern IN Clinical Trials
New Albany, Indiana, 47150, United States
Skin Specialists PC
Omaha, Nebraska, 68144, United States
Cameron Dermatology
New York, New York, 10023, United States
Icahn School Of Med At Mount Sinai
New York, New York, 10029, United States
OnSite Clinical Solutions LLC
Huntersville, North Carolina, 28078, United States
Optima Research Boardman
Boardman, Ohio, 44512, United States
Apex Clinical Research Center LLC
Mayfield Heights, Ohio, 44124, United States
Clinical Research Ctr of Carolinas
Charleston, South Carolina, 29407, United States
Center for Clinical Studies-Lee
Webster, Texas, 77598, United States
Novartis Investigative Site
Caba, Buenos Aires, C1119ACN, Argentina
Novartis Investigative Site
CABA, Buenos Aires, C1425BEA, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, S2000DBS, Argentina
Novartis Investigative Site
CABA, C1012AAY, Argentina
Novartis Investigative Site
CABA, C1428DZF, Argentina
Novartis Investigative Site
Sydney, New South Wales, 2010, Australia
Novartis Investigative Site
Melbourne, Victoria, 3004, Australia
Novartis Investigative Site
Edmonton, Alberta, T6G 1C3, Canada
Novartis Investigative Site
London, Ontario, N6H 5L5, Canada
Novartis Investigative Site
Montreal, Quebec, H1Y 3L1, Canada
Novartis Investigative Site
Québec, Quebec, G1V 4T3, Canada
Novartis Investigative Site
Beijing, 100144, China
Novartis Investigative Site
Ipoh, Perak, 30450, Malaysia
Novartis Investigative Site
Kota Kinabalu, Sabah, 88586, Malaysia
Novartis Investigative Site
Selangor Darul Ehsan, 68100, Malaysia
Novartis Investigative Site
Barcelona, Catalonia, 08003, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2026
First Posted
June 24, 2026
Study Start
July 10, 2026
Primary Completion (Estimated)
October 24, 2031
Study Completion (Estimated)
October 24, 2031
Last Updated
September 28, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.