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RECRUITING

NCT06799000

PHASE3

A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1)

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-1)

Key Details

Gender

All

Age Range

12 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

555

Start Date

2025-01-31

Completion Date

2028-01-18

Last Updated

2026-03-12

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 (145)

Medical Dermatology Specialists

Phoenix, Arizona, United States

Johnson Dermatology

Fort Smith, Arkansas, United States

Arkansas Research Trials

North Little Rock, Arkansas, United States

Cheryl Effron MD Inc

Anaheim, California, United States

Physioseq

Sacramento, California, United States

Olive View UCLA Medical Center

Sylmar, California, United States

Clinical Trials Research Institute

Thousand Oaks, California, United States

Howard University College of Medicine

Washington D.C., District of Columbia, United States

Florida Academic Centers Research and Education LLC

Coral Gables, Florida, United States

University of MiamiHealth System

Miami, Florida, United States

Ziaderm Research LLC

North Miami Beach, Florida, United States

Revival Research Institute LLC

Evans, Georgia, United States

Gwinnett Clinical Research Center

Snellville, Georgia, United States

Immunology-Rheumatology Research

Suwanee, Georgia, United States

Illinois Dermatology Institute

Chicago, Illinois, United States

Dawes Fretzin Clinical Rea Group

Indianapolis, Indiana, United States

Equity Medical LLC

Bowling Green, Kentucky, United States

Dermat. and Adv. Aesthetics

Lake Charles, Louisiana, United States

Michigan Center for Rsrch Company

Clarkston, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Revival Research Institute

Troy, Michigan, United States

University of Mississippi Med Ctr

Jackson, Mississippi, United States

Care Access Hoboken

Hoboken, New Jersey, United States

Forest Hills Dermatology Group

New York, New York, United States

Icahn School Of Med At Mount Sinai

New York, New York, United States

Skinsearch of Rochester Inc

Rochester, New York, United States

OnSite Clinical Solutions LLC

Huntersville, North Carolina, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Unity Clinical Research

Oklahoma City, Oklahoma, United States

Essential Medical Research

Tulsa, Oklahoma, United States

UP Medical Center H System

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina MUSC

Charleston, South Carolina, United States

Advanced Research Experts

Nashville, Tennessee, United States

Bellaire Dermatology Associates

Bellaire, Texas, United States

RFSA Dermatology

San Antonio, Texas, United States

Virginia Clinical Research

Norfolk, Virginia, United States

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

CABA, Argentina

Novartis Investigative Site

Phillip, Australian Capital Territory, Australia

Novartis Investigative Site

Sydney, New South Wales, Australia

Novartis Investigative Site

Westmead, New South Wales, Australia

Novartis Investigative Site

Melbourne, Victoria, Australia

Novartis Investigative Site

Parkville, Victoria, Australia

Novartis Investigative Site

Pleven, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Stara Zagora, Bulgaria

Novartis Investigative Site

Surrey, British Columbia, Canada

Novartis Investigative Site

St. John's, Newfoundland and Labrador, Canada

Novartis Investigative Site

Hamilton, Ontario, Canada

Novartis Investigative Site

Richmond Hill, Ontario, Canada

Novartis Investigative Site

Québec, Quebec, Canada

Novartis Investigative Site

Saint-Jérôme, Quebec, Canada

Novartis Investigative Site

Fuzhou, Fujian, China

Novartis Investigative Site

Guangzhou, Guangdong, China

Novartis Investigative Site

Wuhan, Hubei, China

Novartis Investigative Site

Changsha, Hunan, China

Novartis Investigative Site

Changchun, Jilin, China

Novartis Investigative Site

Shenyang, Liaoning, China

Novartis Investigative Site

Xian, Shanxi, China

Novartis Investigative Site

Chengdu, Sichuan, China

Novartis Investigative Site

Ürümqi, Xinjiang, China

Novartis Investigative Site

Ningbo, Zhejiang, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Jinan, China

Novartis Investigative Site

Barranquilla, Atlántico, Colombia

Novartis Investigative Site

Bogota, Cundinamarca, Colombia

Novartis Investigative Site

Cali, Valle del Cauca Department, Colombia

Novartis Investigative Site

Medellín, Colombia

Novartis Investigative Site

Kobenhavn N V, Denmark

Novartis Investigative Site

Roskilde, Denmark

Novartis Investigative Site

Langenau, Baden-Wurttemberg, Germany

Novartis Investigative Site

Darmstadt, Hesse, Germany

Novartis Investigative Site

Stade, Lower Saxony, Germany

Novartis Investigative Site

Dresden, Saxony, Germany

Novartis Investigative Site

Halle, Saxony-Anhalt, Germany

Novartis Investigative Site

Aachen, Germany

Novartis Investigative Site

Berlin, Germany

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Berlin, Germany

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Bochum, Germany

Novartis Investigative Site

Bonn, Germany

Novartis Investigative Site

Erlangen, Germany

Novartis Investigative Site

Hamburg, Germany

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Hanover, Germany

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Kiel, Germany

Novartis Investigative Site

Mainz, Germany

Novartis Investigative Site

Memmingen, Germany

Novartis Investigative Site

Münster, Germany

Novartis Investigative Site

Chaïdári, Greece

Novartis Investigative Site

Heraklion Crete., Greece

Novartis Investigative Site

Thessaloniki, Greece

Novartis Investigative Site

Ancona, AN, Italy

Novartis Investigative Site

Brescia, BS, Italy

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Catania, CT, Italy

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Cona, FE, Italy

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Florence, FI, Italy

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Milan, MI, Italy

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Rozzano, MI, Italy

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Modena, MO, Italy

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Pisa, PI, Italy

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Roma, RM, Italy

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Torino, TO, Italy

Novartis Investigative Site

Muar town, Johor, Malaysia

Novartis Investigative Site

Kota Bharu, Kelantan, Malaysia

Novartis Investigative Site

George Town, Pulau Pinang, Malaysia

Novartis Investigative Site

Kuching, Sarawak, Malaysia

Novartis Investigative Site

Kuala Terengganu, Terengganu, Malaysia

Novartis Investigative Site

Kuala Lumpur, Malaysia

Novartis Investigative Site

Guadalajara, Jalisco, Mexico

Novartis Investigative Site

Guadalajara, Jalisco, Mexico

Novartis Investigative Site

Cuauhtémoc, Mexico City, Mexico

Novartis Investigative Site

Chihuahua City, Mexico

Novartis Investigative Site

Bydgoszcz, Poland

Novartis Investigative Site

Gdansk, Poland

Novartis Investigative Site

Lodz, Poland

Novartis Investigative Site

Almada, Portugal

Novartis Investigative Site

Braga, Portugal

Novartis Investigative Site

Coimbra, Portugal

Novartis Investigative Site

Lisbon, Portugal

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Lisbon, Portugal

Novartis Investigative Site

Porto, Portugal

Novartis Investigative Site

Bratislava, Slovakia

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Bratislava, Slovakia

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Prešov, Slovakia

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Trnava, Slovakia

Novartis Investigative Site

Raslouw Centurion, Gauteng, South Africa

Novartis Investigative Site

Soweto, Gauteng, South Africa

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Cape Town, South Africa

Novartis Investigative Site

Durban, South Africa

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Cadiz, Andalusia, Spain

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Badalona, Barcelona, Spain

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Sabadell, Barcelona, Spain

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Barcelona, Catalonia, Spain

Novartis Investigative Site

Manises, Valencia, Spain

Novartis Investigative Site

Valencia, Valencia, Spain

Novartis Investigative Site

Madrid, Spain

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Madrid, Spain

Novartis Investigative Site

Valencia, Spain

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Basel, Switzerland

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Bern, Switzerland

Novartis Investigative Site

Zurich, Switzerland

Novartis Investigative Site

Kaohsiung City, Taiwan

Novartis Investigative Site

Taipei, Taiwan

Novartis Investigative Site

Taoyuan District, Taiwan

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 (RECHARGE 1)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (145)