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RECRUITING

NCT06840392

PHASE3

A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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).

Official title: 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 and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE-2)

Key Details

Gender

All

Age Range

12 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

555

Start Date

2025-03-20

Completion Date

2028-02-07

Last Updated

2026-03-11

Healthy Volunteers

Conditions

Hidradenitis Suppurativa

Interventions

DRUG

Remibrutinib Dose A

Remibrutinib Dose A (oral)

DRUG

Remibrutinib Dose B

Remibrutinib Dose B (oral)

DRUG

Placebo 1

Placebo matching to remibrutinib Dose A (oral)

DRUG

Placebo 2

Placebo matching to remibrutinib Dose B (oral)

Key Inclusion Criteria: 1. Male and female participants ≥ 12 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.

Locations (138)

Total Skin and Beauty Dermatology Center PC

Birmingham, Alabama, United States

CTT Research

Gilbert, Arizona, United States

Ctr Dermatology and Plastic Surgery

Scottsdale, Arizona, United States

Ctr for Dermatology Clinical Res

Fremont, California, United States

USC Keck School of Medicine

Los Angeles, California, United States

MedDerm Associates

San Diego, California, United States

Driven Research

Coral Gables, Florida, United States

Floridian Research Institute

Miami, Florida, United States

Sarasota Arthritis Res Ctr

Sarasota, Florida, United States

University Of South Florida

Tampa, Florida, United States

Emory School of Med Dermatology

Atlanta, Georgia, United States

Atlanta Biomedical Clin Res LLC

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Endeavor Health

Glenview, Illinois, United States

Dundee Dermatology

West Dundee, Illinois, United States

Southern IN Clinical Trials

New Albany, Indiana, United States

Beth Israel Deaconess Med Center

Boston, Massachusetts, United States

Metro Boston Clinical Partners

Brighton, Massachusetts, United States

Clinical Research Inst of MI

Chesterfield, Michigan, United States

Deluxe Dermatology

St Louis, Missouri, United States

Skin Specialists PC

Omaha, Nebraska, United States

Vivida Dermatology

Las Vegas, Nevada, United States

North Shore University Hospital

New Hyde Park, New York, United States

Cameron Dermatology

New York, New York, United States

Optima Research Boardman

Boardman, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Wright State University

Fairborn, Ohio, United States

Apex Clinical Research Center LLC

Mayfield Heights, Ohio, United States

Clinical Research Ctr of Carolinas

Charleston, South Carolina, United States

Goodlettsville Dermatology Research

Goodlettsville, Tennessee, United States

Accurate Clinical Research

Humble, Texas, United States

Austin Inst for Clinical Research

Pflugerville, Texas, United States

Center for Clinical Studies-Lee

Webster, Texas, United States

Care Access Alexandria

Arlington, Virginia, United States

Complexions Dermatology

Danville, Virginia, United States

Forefront Dermatology

Vienna, Virginia, United States

Novartis Investigative Site

Berazategui, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Argentina

Novartis Investigative Site

Caba, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative Site

Linz, Austria

Novartis Investigative Site

Brussels, Brussels Capital, Belgium

Novartis Investigative Site

Woluwe-Saint-Lambert, Brussels Capital, Belgium

Novartis Investigative Site

Leuven, Vlaams Brabant, Belgium

Novartis Investigative Site

Liège, Belgium

Novartis Investigative Site

Edmonton, Alberta, Canada

Novartis Investigative Site

London, Ontario, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Québec, Quebec, Canada

Novartis Investigative Site

Sherbrooke, Quebec, Canada

Novartis Investigative Site

Medellín, Antioquia, Colombia

Novartis Investigative Site

Bogota, Cundinamarca, Colombia

Novartis Investigative Site

Bogota, Cundinamarca, Colombia

Novartis Investigative Site

Medellín, Colombia

Novartis Investigative Site

Karlovy Vary, Czechia

Novartis Investigative Site

Plzen Bolevec, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Brest, France

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La Rochelle, France

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Lyon, France

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Nice, France

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Reims, France

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Rouen, France

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Toulouse, France

Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Novartis Investigative Site

Würzburg, Bavaria, Germany

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany

Novartis Investigative Site

Düsseldorf, North Rhine-Westphalia, Germany

Novartis Investigative Site

Merzig, Saarland, Germany

Novartis Investigative Site

Leipzig, Saxony, Germany

Novartis Investigative Site

Bad Bentheim, Germany

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Berlin, Germany

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Dessau, Germany

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Dortmund, Germany

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Essen, Germany

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Hamburg, Germany

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Lübeck, Germany

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Minden, Germany

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München, Germany

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Tübingen, Germany

Novartis Investigative Site

Athens, Greece

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Chaïdári, Greece

Novartis Investigative Site

Thessaloniki, Greece

Novartis Investigative Site

Pécs, Baranya, Hungary

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, Hungary

Novartis Investigative Site

Debrecen, Hajdú-Bihar, Hungary

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Kecskemét, Hungary

Novartis Investigative Site

Szeged, Hungary

Novartis Investigative Site

Kuala Lumpur, Kuala Lumpur, Malaysia

Novartis Investigative Site

Ipoh, Perak, Malaysia

Novartis Investigative Site

Kota Kinabalu, Sabah, Malaysia

Novartis Investigative Site

Johor Bahru, Malaysia

Novartis Investigative Site

Selangor Darul Ehsan, Malaysia

Novartis Investigative Site

Wilayah Persekutuan, Malaysia

Novartis Investigative Site

Monterrey, Nuevo León, Mexico

Novartis Investigative Site

Culiacán, Sinaloa, Mexico

Novartis Investigative Site

Durango, Mexico

Novartis Investigative Site

Warsaw, Masovian Voivodeship, Poland

Novartis Investigative Site

Warsaw, Poland

Novartis Investigative Site

Warsaw, Poland

Alma Cruz-Santana Private Practice

Carolina, Puerto Rico

Novartis Investigative Site

Bucharest, District 2, Romania

Novartis Investigative Site

Bucharest, District 2, Romania

Novartis Investigative Site

Bucharest, Romania

Novartis Investigative Site

Timișoara, Romania

Novartis Investigative Site

Granada, Andalusia, Spain

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Palma, Balearic Islands, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Granollers, Spain

Novartis Investigative Site

Las Palmas GC, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Pontevedra, Spain

Novartis Investigative Site

Seville, Spain

Novartis Investigative Site

Valencia, Spain

Novartis Investigative Site

Izmir, Balcova, Turkey (Türkiye)

Novartis Investigative Site

Ankara, Bilkent-Cankaya, Turkey (Türkiye)

Novartis Investigative Site

Izmir, Buca, Turkey (Türkiye)

Novartis Investigative Site

Aydin, Efeler, Turkey (Türkiye)

Novartis Investigative Site

Denizli, Kinikli, Turkey (Türkiye)

Novartis Investigative Site

Ankara, Sihhiye-Altindag, Turkey (Türkiye)

Novartis Investigative Site

Ankara, Yenimahalle, Turkey (Türkiye)

Novartis Investigative Site

Mersin, Yenisehir, Turkey (Türkiye)

Novartis Investigative Site

Izmir, Turkey (Türkiye)

Novartis Investigative Site

Kecioren Ankara, Turkey (Türkiye)

Novartis Investigative Site

Leeds, West Yorkshire, United Kingdom

Novartis Investigative Site

Bristol, United Kingdom

Novartis Investigative Site

Cardiff, United Kingdom

Novartis Investigative Site

London, United Kingdom

Novartis Investigative Site

London, United Kingdom

Novartis Investigative Site

London, United Kingdom

Novartis Investigative Site

Southampton, United Kingdom

Clinical Research Directory

A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (138)