NCT07665437From ClinicalTrials.govRecruiting

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

Hidradenitis Suppurativa

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Novartis Pharmaceuticals
Enrolment target: 710
Started: 10 July 2026
Main results due: 24 October 2031
Study sites: 34
Registry updated: 28 September 2026

Can you take part?

Ages 18 years to 100 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(34)

Johnson Dermatology
Fort Smith, Arkansas, United States
Recruiting
Ctr for Dermatology Clinical Res
Fremont, California, United States
Recruiting
USC Keck School of Medicine
Los Angeles, California, United States
Recruiting
Olive View UCLA Medical Center
Sylmar, California, United States
Recruiting
Clinical Trials Research Institute
Thousand Oaks, California, United States
Recruiting
Floridian Research Institute
Miami, Florida, United States
Recruiting
University Of South Florida
Tampa, Florida, United States
Recruiting
Endeavor Health
Glenview, Illinois, United States
Recruiting
Dundee Dermatology
West Dundee, Illinois, United States
Recruiting
Southern IN Clinical Trials
New Albany, Indiana, United States
Recruiting
Skin Specialists PC
Omaha, Nebraska, United States
Recruiting
Cameron Dermatology
New York, New York, United States
Recruiting
Icahn School Of Med At Mount Sinai
New York, New York, United States
Recruiting
OnSite Clinical Solutions LLC
Huntersville, North Carolina, United States
Recruiting
Optima Research Boardman
Boardman, Ohio, United States
Recruiting
Apex Clinical Research Center LLC
Mayfield Heights, Ohio, United States
Recruiting
Clinical Research Ctr of Carolinas
Charleston, South Carolina, United States
Recruiting
Center for Clinical Studies-Lee
Webster, Texas, United States
Recruiting
Novartis Investigative Site
Caba, Buenos Aires, Argentina
Recruiting
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Recruiting
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina
Recruiting
Novartis Investigative Site
CABA, Argentina
Recruiting
Novartis Investigative Site
CABA, Argentina
Recruiting
Novartis Investigative Site
Sydney, New South Wales, Australia
Recruiting
Novartis Investigative Site
Melbourne, Victoria, Australia
Recruiting
Novartis Investigative Site
Edmonton, Alberta, Canada
Recruiting
Novartis Investigative Site
London, Ontario, Canada
Recruiting
Novartis Investigative Site
Montreal, Quebec, Canada
Recruiting
Novartis Investigative Site
Québec, Quebec, Canada
Recruiting
Novartis Investigative Site
Beijing, China
Recruiting
Novartis Investigative Site
Ipoh, Perak, Malaysia
Recruiting
Novartis Investigative Site
Kota Kinabalu, Sabah, Malaysia
Recruiting
Novartis Investigative Site
Selangor Darul Ehsan, Malaysia
Recruiting
Novartis Investigative Site
Barcelona, Catalonia, Spain
Recruiting

Showing 34 of 34 sites. 34 of the 34 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07665437. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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