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)

NCT06799000 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CLOU064J123012024-513282-39-00
• Study Type: interventional
• Target: 588
• Locations: 20 countries
• Sites: 138

Brief 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).

Conditions

Hidradenitis Suppurativa

Keywords

Bruton's tyrosine kinase (BTK) inhibitor; Hidradenitis Suppurativa; HS; Hidradenitis Suppurativa clinical response; HiSCR; remibrutinib; LOU064; Hidradenitides, Suppurativa; Hidradenitis, Suppurativa; Suppurativa Hidradenitides; Suppurativa Hidradenitis; Acne inversa,; Verneuil disease; Inflammatory skin disease; Chronic skin condition

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with Hidradenitis Suppurativa clinical response 50 (HiSCR50) at Week 16

  HiSCR50 is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and in the number of draining tunnels/fistulae compared to baseline.

  Week 16

Secondary Outcomes (8)

• Proportion of participants with Abscesses and inflammatory nodules 50 (AN50) response at Week 16

  Week 16

• Percentage change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16

  From baseline up to Week 16

• Proportion of participants with HiSCR75 response at Week 16

  Week 16

• Proportion of participants experiencing Hidradenitis Suppurativa (HS) flares at Week 16

  Up to Week 16

• Proportion of participants with HiSCR50 response at Week 8

  Week 8

Study Arms (3)

Remibrutinib Dose A (Treatment Period 1 and 2)

EXPERIMENTAL

Participants randomized to receive remibrutinib Dose A during Treatment Period 1 and 2

Drug: Remibrutinib Dose A

Remibrutinib Dose B (Treatment Period 1 and 2)

EXPERIMENTAL

Participants randomized to receive remibrutinib Dose B during Treatment Period 1 and 2

Drug: Remibrutinib Dose B

Placebo (Treatment Period 1) + remibrutinib Dose B (Treatment Period 2)

PLACEBO COMPARATOR

Participants randomized to receive placebo during Treatment Period 1 followed by remibrutinib dose B during Treatment Period 2

Drug: Remibrutinib Dose B; Drug: Placebo 1; Drug: Placebo 2

Interventions

Placebo 1 DRUG

Placebo matching to remibrutinib Dose A (oral)

Placebo (Treatment Period 1) + remibrutinib Dose B (Treatment Period 2)

Placebo 2 DRUG

Placebo matching to remibrutinib Dose B (oral)

Placebo (Treatment Period 1) + remibrutinib Dose B (Treatment Period 2)

Remibrutinib Dose A DRUG

Remibrutinib Dose A (oral)

Also known as: LOU064

Remibrutinib Dose A (Treatment Period 1 and 2)

Remibrutinib Dose B DRUG

Remibrutinib Dose B (oral)

Also known as: LOU064

Placebo (Treatment Period 1) + remibrutinib Dose B (Treatment Period 2); Remibrutinib Dose B (Treatment Period 1 and 2)

Eligibility Criteria

• Age: 12 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants ≥ 12 years of age at the time of signing of the informed consent.
• Diagnosis of HS based on clinical history and physical examination for at least 6 months prior to the Baseline visit.
• 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)

You may not qualify if:

• Presence of more than 20 fistulae/tunnels (both draining and non-draining) in total at baseline.
• Any active skin disease or conditions that may interfere with the assessment of HS.
• Previous exposure to remibrutinib or other BTK inhibitors.
• 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.
• Significant bleeding risk or coagulation disorders.
• History of gastrointestinal bleeding.
• Requirement for anti-platelet (except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d) or anti-coagulant medication.
• History or current hepatic disease.
• 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.
• History of hypersensitivity to any of the study drug constituents.
• 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.
• 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.
• Major surgery within 8 weeks prior to screening or planned surgery for the duration of the study.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (138)

Medical Dermatology Specialists

Phoenix, Arizona, 85006, United States

Location

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

Arkansas Research Trials

North Little Rock, Arkansas, 72117, United States

Location

Cheryl Effron MD Inc

Anaheim, California, 92807, United States

Location

Physioseq

Sacramento, California, 95826, United States

Location

Olive View UCLA Medical Center

Sylmar, California, 91342, United States

Location

Clinical Trials Research Institute

Thousand Oaks, California, 91320, United States

Location

Howard University College of Medicine

Washington D.C., District of Columbia, 20060, United States

Location

Florida Academic Centers Research and Education LLC

Coral Gables, Florida, 33134, United States

Location

University of MiamiHealth System

Miami, Florida, 33125, United States

Location

Ziaderm Research LLC

North Miami Beach, Florida, 33162, United States

Location

Revival Research Institute LLC

Evans, Georgia, 30809, United States

Location

Gwinnett Clinical Research Center

Snellville, Georgia, 30078, United States

Location

Immunology-Rheumatology Research

Suwanee, Georgia, 30024, United States

Location

Illinois Dermatology Institute

Chicago, Illinois, 60602, United States

Location

Dawes Fretzin Clinical Rea Group

Indianapolis, Indiana, 46256, United States

Location

Equity Medical LLC

Bowling Green, Kentucky, 42104, United States

Location

Dermat. and Adv. Aesthetics

Lake Charles, Louisiana, 70605, United States

Location

Michigan Center for Rsrch Company

Clarkston, Michigan, 48346, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202-2689, United States

Location

Revival Research Institute

Troy, Michigan, 48084, United States

Location

University of Mississippi Med Ctr

Jackson, Mississippi, 39216, United States

Location

Care Access Hoboken

Hoboken, New Jersey, 07030, United States

Location

Forest Hills Dermatology Group

New York, New York, 10003, United States

Location

Icahn School Of Med At Mount Sinai

New York, New York, 10029, United States

Location

Skinsearch of Rochester Inc

Rochester, New York, 14623, United States

Location

OnSite Clinical Solutions LLC

Huntersville, North Carolina, 28078, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27104, United States

Location

Unity Clinical Research

Oklahoma City, Oklahoma, 73118, United States

Location

Essential Medical Research

Tulsa, Oklahoma, 74137, United States

Location

UP Medical Center H System

Pittsburgh, Pennsylvania, 15213-3403, United States

Location

Medical University of South Carolina MUSC

Charleston, South Carolina, 29425, United States

Location

Advanced Research Experts

Nashville, Tennessee, 37211, United States

Location

Bellaire Dermatology Associates

Bellaire, Texas, 77401, United States

Location

RFSA Dermatology

San Antonio, Texas, 78213, United States

Location

Virginia Clinical Research

Norfolk, Virginia, 23507, United States

Location

Novartis Investigative Site

Caba, Buenos Aires, C1119ACN, Argentina

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Novartis Investigative Site

CABA, Buenos Aires, C1425BEA, Argentina

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Novartis Investigative Site

Rosario, Santa Fe Province, 2000, Argentina

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Novartis Investigative Site

CABA, C1428DZF, Argentina

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Novartis Investigative Site

Phillip, Australian Capital Territory, 2606, Australia

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Novartis Investigative Site

Sydney, New South Wales, 2010, Australia

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Novartis Investigative Site

Westmead, New South Wales, 2145, Australia

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Novartis Investigative Site

Melbourne, Victoria, 3004, Australia

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Novartis Investigative Site

Parkville, Victoria, 3050, Australia

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Novartis Investigative Site

Sofia, 1407, Bulgaria

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Novartis Investigative Site

Stara Zagora, 6000, Bulgaria

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Novartis Investigative Site

Surrey, British Columbia, V3V 0C6, Canada

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Novartis Investigative Site

St. John's, Newfoundland and Labrador, A1E 1V4, Canada

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Novartis Investigative Site

Hamilton, Ontario, L8L 3C3, Canada

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Novartis Investigative Site

Richmond Hill, Ontario, L4C 9M7, Canada

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Novartis Investigative Site

Québec, Quebec, G1W 4R4, Canada

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Novartis Investigative Site

Saint-Jérôme, Quebec, J7Z 7E2, Canada

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Novartis Investigative Site

Fuzhou, Fujian, 350025, China

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Novartis Investigative Site

Guangzhou, Guangdong, 510000, China

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Novartis Investigative Site

Wuhan, Hubei, 430022, China

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Novartis Investigative Site

Changsha, Hunan, 410008, China

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Novartis Investigative Site

Changchun, Jilin, 130021, China

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Novartis Investigative Site

Shenyang, Liaoning, 110011, China

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Novartis Investigative Site

Xian, Shanxi, 710004, China

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Novartis Investigative Site

Chengdu, Sichuan, 610041, China

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Novartis Investigative Site

Ürümqi, Xinjiang, 830001, China

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Novartis Investigative Site

Ningbo, Zhejiang, 315016, China

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Novartis Investigative Site

Beijing, 100144, China

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Novartis Investigative Site

Jinan, 250012, China

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Novartis Investigative Site

Barranquilla, Atlántico, 080002, Colombia

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Novartis Investigative Site

Bogota, Cundinamarca, 110221, Colombia

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Novartis Investigative Site

Cali, Valle del Cauca Department, 760032, Colombia

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Novartis Investigative Site

Medellín, 050034, Colombia

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Novartis Investigative Site

Roskilde, 4000, Denmark

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Novartis Investigative Site

Langenau, Baden-Wurttemberg, 89129, Germany

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Novartis Investigative Site

Darmstadt, Hesse, 64283, Germany

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Novartis Investigative Site

Dresden, Saxony, 01307, Germany

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Novartis Investigative Site

Halle, Saxony-Anhalt, 06108, Germany

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Novartis Investigative Site

Berlin, 10789, Germany

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Novartis Investigative Site

Berlin, 13353, Germany

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Novartis Investigative Site

Bochum, 44791, Germany

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Novartis Investigative Site

Bonn, 53105, Germany

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Novartis Investigative Site

Erlangen, 91054, Germany

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Novartis Investigative Site

Hamburg, 20095, Germany

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Novartis Investigative Site

Hanover, 30159, Germany

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Novartis Investigative Site

Kiel, 24105, Germany

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Novartis Investigative Site

Mainz, 55131, Germany

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Novartis Investigative Site

Münster, 48149, Germany

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Novartis Investigative Site

Chaïdári, 124 62, Greece

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Novartis Investigative Site

Heraklion Crete., 715 00, Greece

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Novartis Investigative Site

Thessaloniki, 546 43, Greece

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Novartis Investigative Site

Ancona, AN, 60126, Italy

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Novartis Investigative Site

Brescia, BS, 25123, Italy

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Novartis Investigative Site

Catania, CT, 95123, Italy

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Novartis Investigative Site

Cona, FE, 44124, Italy

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Novartis Investigative Site

Florence, FI, 50122, Italy

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Novartis Investigative Site

Rozzano, MI, 20089, Italy

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Novartis Investigative Site

Modena, MO, 41124, Italy

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Novartis Investigative Site

Pisa, PI, 56126, Italy

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Novartis Investigative Site

Roma, RM, 00168, Italy

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Novartis Investigative Site

Torino, TO, 10126, Italy

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Novartis Investigative Site

Muar town, Johor, 84000, Malaysia

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Novartis Investigative Site

George Town, Pulau Pinang, 10450, Malaysia

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Novartis Investigative Site

Kuching, Sarawak, 93586, Malaysia

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Novartis Investigative Site

Kuala Terengganu, Terengganu, 20400, Malaysia

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Novartis Investigative Site

Kuala Lumpur, 59100, Malaysia

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Novartis Investigative Site

Guadalajara, Jalisco, 44340, Mexico

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Novartis Investigative Site

Guadalajara, Jalisco, 44650, Mexico

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Novartis Investigative Site

Cuauhtémoc, Mexico City, 06100, Mexico

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Novartis Investigative Site

Chihuahua City, 31203, Mexico

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Novartis Investigative Site

Bydgoszcz, 85-094, Poland

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Novartis Investigative Site

Gdansk, 80-214, Poland

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Novartis Investigative Site

Lodz, 90-436, Poland

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Novartis Investigative Site

Almada, 2805-267, Portugal

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Novartis Investigative Site

Braga, 4710243, Portugal

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Novartis Investigative Site

Coimbra, 3004-561, Portugal

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Novartis Investigative Site

Lisbon, 1169-050, Portugal

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Novartis Investigative Site

Lisbon, 1998-018, Portugal

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Novartis Investigative Site

Porto, 4099-001, Portugal

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Novartis Investigative Site

Bratislava, 811 09, Slovakia

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Novartis Investigative Site

Bratislava, 813 69, Slovakia

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Novartis Investigative Site

Prešov, 080 01, Slovakia

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Novartis Investigative Site

Trnava, 917 02, Slovakia

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Novartis Investigative Site

Raslouw Centurion, Gauteng, 0157, South Africa

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Novartis Investigative Site

Soweto, Gauteng, 2013, South Africa

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Novartis Investigative Site

Cape Town, 7505, South Africa

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Novartis Investigative Site

Durban, 4058, South Africa

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Novartis Investigative Site

Cadiz, Andalusia, 11009, Spain

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Novartis Investigative Site

Badalona, Barcelona, 08916, Spain

Location

Novartis Investigative Site

Sabadell, Barcelona, 08208, Spain

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Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

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Novartis Investigative Site

Manises, Valencia, 46940, Spain

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Novartis Investigative Site

Valencia, Valencia, 46017, Spain

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Novartis Investigative Site

Madrid, 28009, Spain

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Novartis Investigative Site

Madrid, 28046, Spain

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Novartis Investigative Site

Valencia, 46014, Spain

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Novartis Investigative Site

Basel, 4031, Switzerland

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Novartis Investigative Site

Bern, 3010, Switzerland

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Novartis Investigative Site

Zurich, 8091, Switzerland

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Novartis Investigative Site

Kaohsiung City, 83301, Taiwan

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Novartis Investigative Site

Taipei, 10002, Taiwan

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Novartis Investigative Site

Taoyuan, 33305, Taiwan

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MeSH Terms

Conditions

Hidradenitis Suppurativa; Hidradenitis; Dermatitis

Interventions

remibrutinib

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Sweat Gland Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: January 31, 2025
• Primary Completion (Estimated): May 17, 2027
• Study Completion (Estimated): October 4, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

SL (4); US (36); BU (2); CH (3); CN (12); ES (9); CO (4); PL (3); ME (4); PT (6); AU (5); TW (3); DK (1); AR (4); GR (3); IT (10); ZA (4); CA (6); MY (5); DE (14)