Last Update: May 06, 2025
A Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, Phase 3 Study Assessing the Efficacy, Safety, and Tolerability of 2 Doses of Remibrutinib Over a 68-week Treatment Period in Adult Patients With Moderate to Severe Hidradenitis Suppurativa
ClinicalTrials.gov Identifier:
Novartis Reference Number:CLOU064J12302
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate to severe hidradenitis suppurativa (HS). The total duration of the study is 76 weeks and consists of: Screening (up to 4 weeks), Treatment Period 1 (16 weeks, double-blind treatment with remibrutinib (Dose A or Dose B) or placebo, Treatment Period 2 (52 weeks, treatment with remibrutinib (Dose A or Dose B) and Safety Follow-Up (treatment-free follow-up for 4 weeks).

Participants who prematurely discontinue study treatment (either during Treatment Period 1 or Treatment Period 2) are encouraged to remain in the study. Participants who do not wish to remain in the study will enter a 4-week Safety Follow-Up period.

Hidradenitis Suppurativa
Phase3
Recruiting
555
Mar 20, 2025
Oct 20, 2028
All
18 Years - 100 Years (Adult, Older Adult)

Interventions

Drug

Placebo 1

Placebo matching to remibrutinib Dose A (oral)
Drug

Placebo 2

Placebo matching to remibrutinib Dose B (oral)
Drug

Remibrutinib Dose A

Remibrutinib Dose A (oral)
Drug

Remibrutinib Dose B

Remibrutinib Dose B (oral)

Eligibility Criteria

Key Inclusion Criteria:

1. Male and female participants ≥ 18 years of age at the time of signing of the informed consent.
2. Diagnosis of HS based on clinical history and physical examination for at least 6 months prior to the Baseline visit.
3. Participants with moderate to severe HS defined as:

* A total of at least 5 AN count (abscesses and/or inflammatory nodules) AND
* Inflammatory lesions should affect at least 2 distinct anatomic areas (e.g., left and right axillae)

Key Exclusion Criteria:

1. Presence of more than 20 fistulae/tunnels (both draining and non-draining) in total at baseline.
2. Any active skin disease or conditions that may interfere with the assessment of HS.
3. Previous exposure to remibrutinib or other BTK inhibitors.
4. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days (for small molecules) prior to randomization, or until the pharmacodynamic effect has returned to baseline (for biologics), whichever is longer.
5. Significant bleeding risk or coagulation disorders.
6. History of gastrointestinal bleeding.
7. Requirement for anti-platelet (except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d) or anti-coagulant medication.
8. History or current hepatic disease.
9. Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the Investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.
10. History of hypersensitivity to any of the study drug constituents.
11. Known or suspected infectious disease that is active, chronic or recurrent which precludes the participant from participating in the trial as per investigator's assessment. These infectious diseases include and are not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and/or known or suspected Human Immunodeficiency Virus (HIV) infection. Should it be required by local regulations and/or considered appropriate by the investigator, an HIV test can be performed to confirm eligibility.
12. History of live attenuated vaccine administration within 6 weeks prior to randomization or requirement to receive these vaccinations at any time while on study treatment.
13. Major surgery within 8 weeks prior to screening or planned surgery for the duration of the study.

Other protocol-defined inclusion/exclusion criteria may apply.

Novartis Investigative Site

Recruiting

Caba,C1012aay,Argentina

Novartis Investigative Site

Recruiting

London,Ontario,N6h 5l5,Canada

Novartis Investigative Site

Recruiting

Montreal,Quebec,H1y 3l1,Canada

Novartis Investigative Site

Recruiting

Quebec,J1g 1x9,Canada

Novartis Investigative Site

Recruiting

Ipoh,Perak,30450,Malaysia

Novartis Investigative Site

Recruiting

Kota Kinabalu,Sabah,88586,Malaysia

Novartis Investigative Site

Recruiting

Wilayah Persekutuan,62502,Malaysia

Complexions Dermatology

Recruiting

Danville,Virginia,24541,United States

Janaya Patron
Keith Robinson

Clinical Research Inst of MI

Recruiting

Chesterfield,Michigan,48047,United States

Natalia Filipof
Karie Simons

Clinical Research Ctr of Carolinas

Recruiting

Charleston,South Carolina,29407,United States

Todd Schlesinger
Amber Thompson

Rivergate Dermatology and Skin Care Center

Recruiting

Goodlettsville,Tennessee,37072-2301,United States

Keith H Loven
Mary Smith

Floridian Research Institute

Recruiting

Miami,Florida,33179,United States

Gretel Trullenque
Yusmara Villa

Endeavor Health

Recruiting

Glenview,Illinois,60077,United States

Joseph Binder
Shannon Ewing

Ohio State University

Recruiting

Columbus,Ohio,43210,United States

Robert Furlong
Jessica Kaffenberger

Austin Inst for Clinical Research

Recruiting

Pflugerville,Texas,78660,United States

Edward Lain
Jenna McMinn

Vivida Dermatology

Recruiting

Las Vegas,Nevada,89148,United States

Victoria Farley

Center for Clinical Studies-Lee

Recruiting

Webster,Texas,77598,United States

Deborah Yetman
Patricia C Lee

Wright State University

Recruiting

Fairborn,Ohio,45324,United States

Craig Rohan

North Shore University Hospital

Recruiting

New Hyde Park,New York,11040,United States

Amit Garg
Kirendra Pasram

Accurate Clinical Research

Recruiting

Humble,Texas,77346,United States

Chinelo Fangtang
Irene Noblitt

Grady Hospital Corporation

Recruiting

Atlanta,Georgia,30303,United States

Lauren Orenstein

Southern IN Clinical Trials

Recruiting

New Albany,Indiana,47150,United States

Christy Nardi
Megan Landis

Ctr Dermatology and Plastic Surgery

Recruiting

Scottsdale,Arizona,85260,United States

Kenneth Steil
Stephen Fuller

Total Skin and Beauty Dermatology Center PC

Recruiting

Birmingham,Alabama,35205,United States

Angela Powell
Rajini Murthy

Forefront Dermatology

Recruiting

Vienna,Virginia,22182,United States

Naiem Issa
Sophia Bortnick

Metro Boston Clinical Partners

Recruiting

Brighton,Massachusetts,02135,United States

Mark Amster
William Calder

Apex Clinical Research Center LLC

Recruiting

Mayfield Heights,Ohio,44124,United States

Hannah Snyder
Jorge Garcia-Zuazaga

Cameron Dermatology

Recruiting

New York,New York,10023,United States

Jennie Mata
Michael Cameron

Care Access Alexandria

Recruiting

Arlington,Virginia,22206,United States

David Bray
Nicole Thornton

Skin Specialists PC

Recruiting

Omaha,Nebraska,68144,United States

Joel Schlessinger
Samantha Jo Johnson

USC Keck School of Medicine

Recruiting

Los Angeles,California,90033,United States

Katrina Lee
Raveena Ghanshani

Ctr for Dermatology Clinical Res

Recruiting

Fremont,California,95438,United States

Natalya Likhareva
Sunil Dhawan

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Novartis Pharmaceuticals

Novartis Pharmaceuticals