An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS

NCT07665437 · tracked via the Priya Life Science USA tracker

Sponsor

Novartis Pharmaceuticals

Phase

Phase 3

Started

2026-07-10

Last updated

2026-09-14

Condition(s) studied

Hidradenitis Suppurativa

Investigational drug(s) / intervention(s)

Remibrutinib

Remibrutinib: Remibrutinib Dose A and B (oral)

Study 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

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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. Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcome measure(s)

Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) — Baseline, up to Week 280
Evaluate the safety of long-term treatment with remibrutinib in adult participants with moderate to severe Hidradenitis Suppurativa.

Trial sites (20)

Facility	City	Region	Status
Johnson Dermatology	Fort Smith	Arkansas	Recruiting
Ctr for Dermatology Clinical Res	Fremont	California	Recruiting
USC Keck School of Medicine	Los Angeles	California	Recruiting
Olive View UCLA Medical Center	Sylmar	California	Recruiting
Clinical Trials Research Institute	Thousand Oaks	California	Recruiting
Endeavor Health	Glenview	Illinois	Recruiting
Dundee Dermatology	West Dundee	Illinois	Recruiting
Southern IN Clinical Trials	New Albany	Indiana	Recruiting
Skin Specialists PC	Omaha	Nebraska	Recruiting
Cameron Dermatology	New York	New York	Recruiting
Optima Research Boardman	Boardman	Ohio	Recruiting
Apex Clinical Research Center LLC	Mayfield Heights	Ohio	Recruiting
Clinical Research Ctr of Carolinas	Charleston	South Carolina	Recruiting
Novartis Investigative Site	Caba	Buenos Aires	Recruiting
Novartis Investigative Site	CABA	Buenos Aires	Recruiting
Novartis Investigative Site	Rosario	Santa Fe Province	Recruiting
Novartis Investigative Site	CABA	Argentina	Recruiting
Novartis Investigative Site	Sydney	New South Wales	Recruiting
Novartis Investigative Site	Melbourne	Victoria	Recruiting
Novartis Investigative Site	London	Ontario	Recruiting

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Other trials for the same condition

Study to Evaluate the Maximal Use of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis Suppurativa Recruiting

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab) Recruiting

A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa Enrolling by invitation

A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy and Who Are Naïve to Biologic Therapy Active, not recruiting

An Open-label, Single-arm Study to Evaluate Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents With Moderate to Severe Hidradenitis Suppurativa (VELA-TEEN) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07665437 on ClinicalTrials.gov ↗ ← All trials in the USA