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 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CLOU064J123012024-513282-39-00
• Study Type: interventional
• Target: 555
• Locations: 20 countries
• Sites: 145

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

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)

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)

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 (145)

Medical Dermatology Specialists

Phoenix, Arizona, 85006, United States

RECRUITING

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

RECRUITING

Arkansas Research Trials

North Little Rock, Arkansas, 72117, United States

RECRUITING

Cheryl Effron MD Inc

Anaheim, California, 92807, United States

RECRUITING

Physioseq

Sacramento, California, 95826, United States

RECRUITING

Olive View UCLA Medical Center

Sylmar, California, 91342, United States

RECRUITING

Clinical Trials Research Institute

Thousand Oaks, California, 91320, United States

RECRUITING

Howard University College of Medicine

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

RECRUITING

Florida Academic Centers Research and Education LLC

Coral Gables, Florida, 33134, United States

RECRUITING

University of MiamiHealth System

Miami, Florida, 33125, United States

RECRUITING

Ziaderm Research LLC

North Miami Beach, Florida, 33162, United States

RECRUITING

Revival Research Institute LLC

Evans, Georgia, 30809, United States

RECRUITING

Gwinnett Clinical Research Center

Snellville, Georgia, 30078, United States

RECRUITING

Immunology-Rheumatology Research

Suwanee, Georgia, 30024, United States

RECRUITING

Illinois Dermatology Institute

Chicago, Illinois, 60602, United States

RECRUITING

Dawes Fretzin Clinical Rea Group

Indianapolis, Indiana, 46256, United States

RECRUITING

Equity Medical LLC

Bowling Green, Kentucky, 42104, United States

RECRUITING

Dermat. and Adv. Aesthetics

Lake Charles, Louisiana, 70605, United States

RECRUITING

Michigan Center for Rsrch Company

Clarkston, Michigan, 48346, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202-2689, United States

RECRUITING

Revival Research Institute

Troy, Michigan, 48084, United States

RECRUITING

University of Mississippi Med Ctr

Jackson, Mississippi, 39216, United States

RECRUITING

Care Access Hoboken

Hoboken, New Jersey, 07030, United States

RECRUITING

Forest Hills Dermatology Group

New York, New York, 10003, United States

RECRUITING

Icahn School Of Med At Mount Sinai

New York, New York, 10029, United States

RECRUITING

Skinsearch of Rochester Inc

Rochester, New York, 14623, United States

RECRUITING

OnSite Clinical Solutions LLC

Huntersville, North Carolina, 28078, United States

RECRUITING

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27104, United States

RECRUITING

Unity Clinical Research

Oklahoma City, Oklahoma, 73118, United States

RECRUITING

Essential Medical Research

Tulsa, Oklahoma, 74137, United States

RECRUITING

UP Medical Center H System

Pittsburgh, Pennsylvania, 15213-3403, United States

RECRUITING

Medical University of South Carolina MUSC

Charleston, South Carolina, 29425, United States

RECRUITING

Advanced Research Experts

Nashville, Tennessee, 37211, United States

RECRUITING

Bellaire Dermatology Associates

Bellaire, Texas, 77401, United States

RECRUITING

RFSA Dermatology

San Antonio, Texas, 78213, United States

RECRUITING

Virginia Clinical Research

Norfolk, Virginia, 23507, United States

RECRUITING

Novartis Investigative Site

Caba, Buenos Aires, C1119ACN, Argentina

RECRUITING

Novartis Investigative Site

CABA, Buenos Aires, C1425BEA, Argentina

RECRUITING

Novartis Investigative Site

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Novartis Investigative Site

CABA, C1428DZF, Argentina

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Novartis Investigative Site

Phillip, Australian Capital Territory, 2606, Australia

RECRUITING

Novartis Investigative Site

Sydney, New South Wales, 2010, Australia

RECRUITING

Novartis Investigative Site

Westmead, New South Wales, 2145, Australia

RECRUITING

Novartis Investigative Site

Melbourne, Victoria, 3004, Australia

RECRUITING

Novartis Investigative Site

Parkville, Victoria, 3050, Australia

RECRUITING

Novartis Investigative Site

Pleven, 5800, Bulgaria

RECRUITING

Novartis Investigative Site

Sofia, 1407, Bulgaria

RECRUITING

Novartis Investigative Site

Stara Zagora, 6000, Bulgaria

RECRUITING

Novartis Investigative Site

Surrey, British Columbia, V3V 0C6, Canada

RECRUITING

Novartis Investigative Site

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

RECRUITING

Novartis Investigative Site

Hamilton, Ontario, L8L 3C3, Canada

RECRUITING

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

RECRUITING

Novartis Investigative Site

Guangzhou, Guangdong, 510000, China

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Novartis Investigative Site

Wuhan, Hubei, 430022, China

RECRUITING

Novartis Investigative Site

Changsha, Hunan, 410008, China

RECRUITING

Novartis Investigative Site

Changchun, Jilin, 130021, China

ACTIVE NOT RECRUITING

Novartis Investigative Site

Shenyang, Liaoning, 110011, China

RECRUITING

Novartis Investigative Site

Xian, Shanxi, 710004, China

RECRUITING

Novartis Investigative Site

Chengdu, Sichuan, 610041, China

RECRUITING

Novartis Investigative Site

Ürümqi, Xinjiang, 830001, China

RECRUITING

Novartis Investigative Site

Ningbo, Zhejiang, 315016, China

RECRUITING

Novartis Investigative Site

Beijing, 100144, China

RECRUITING

Novartis Investigative Site

Jinan, 250012, China

RECRUITING

Novartis Investigative Site

Barranquilla, Atlántico, 080002, Colombia

RECRUITING

Novartis Investigative Site

Bogota, Cundinamarca, 110221, Colombia

RECRUITING

Novartis Investigative Site

Cali, Valle del Cauca Department, 760032, Colombia

RECRUITING

Novartis Investigative Site

Medellín, 050034, Colombia

RECRUITING

Novartis Investigative Site

Kobenhavn N V, 2400, Denmark

RECRUITING

Novartis Investigative Site

Roskilde, 4000, Denmark

RECRUITING

Novartis Investigative Site

Langenau, Baden-Wurttemberg, 89129, Germany

RECRUITING

Novartis Investigative Site

Darmstadt, Hesse, 64283, Germany

RECRUITING

Novartis Investigative Site

Stade, Lower Saxony, 21682, Germany

RECRUITING

Novartis Investigative Site

Dresden, Saxony, 01307, Germany

RECRUITING

Novartis Investigative Site

Halle, Saxony-Anhalt, 06108, Germany

RECRUITING

Novartis Investigative Site

Aachen, 52074, Germany

RECRUITING

Novartis Investigative Site

Berlin, 10789, Germany

RECRUITING

Novartis Investigative Site

Berlin, 13353, Germany

RECRUITING

Novartis Investigative Site

Bochum, 44791, Germany

RECRUITING

Novartis Investigative Site

Bonn, 53105, Germany

RECRUITING

Novartis Investigative Site

Erlangen, 91054, Germany

RECRUITING

Novartis Investigative Site

Hamburg, 20095, Germany

RECRUITING

Novartis Investigative Site

Hanover, 30159, Germany

RECRUITING

Novartis Investigative Site

Kiel, 24105, Germany

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Novartis Investigative Site

Mainz, 55131, Germany

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Novartis Investigative Site

Memmingen, 87700, Germany

RECRUITING

Novartis Investigative Site

Münster, 48149, Germany

RECRUITING

Novartis Investigative Site

Chaïdári, 124 62, Greece

RECRUITING

Novartis Investigative Site

Heraklion Crete., 715 00, Greece

RECRUITING

Novartis Investigative Site

Thessaloniki, 546 43, Greece

RECRUITING

Novartis Investigative Site

Ancona, AN, 60126, Italy

RECRUITING

Novartis Investigative Site

Brescia, BS, 25123, Italy

RECRUITING

Novartis Investigative Site

Catania, CT, 95123, Italy

RECRUITING

Novartis Investigative Site

Cona, FE, 44124, Italy

RECRUITING

Novartis Investigative Site

Florence, FI, 50122, Italy

RECRUITING

Novartis Investigative Site

Milan, MI, 20122, Italy

RECRUITING

Novartis Investigative Site

Rozzano, MI, 20089, Italy

RECRUITING

Novartis Investigative Site

Modena, MO, 41124, Italy

RECRUITING

Novartis Investigative Site

Pisa, PI, 56126, Italy

RECRUITING

Novartis Investigative Site

Roma, RM, 00168, Italy

RECRUITING

Novartis Investigative Site

Torino, TO, 10126, Italy

RECRUITING

Novartis Investigative Site

Muar town, Johor, 84000, Malaysia

RECRUITING

Novartis Investigative Site

Kota Bharu, Kelantan, 15586, Malaysia

RECRUITING

Novartis Investigative Site

George Town, Pulau Pinang, 10450, Malaysia

RECRUITING

Novartis Investigative Site

Kuching, Sarawak, 93586, Malaysia

RECRUITING

Novartis Investigative Site

Kuala Terengganu, Terengganu, 20400, Malaysia

RECRUITING

Novartis Investigative Site

Kuala Lumpur, 59100, Malaysia

RECRUITING

Novartis Investigative Site

Guadalajara, Jalisco, 44340, Mexico

RECRUITING

Novartis Investigative Site

Guadalajara, Jalisco, 44650, Mexico

RECRUITING

Novartis Investigative Site

Cuauhtémoc, Mexico City, 06100, Mexico

RECRUITING

Novartis Investigative Site

Chihuahua City, 31203, Mexico

RECRUITING

Novartis Investigative Site

Bydgoszcz, 85-094, Poland

RECRUITING

Novartis Investigative Site

Gdansk, 80-214, Poland

RECRUITING

Novartis Investigative Site

Lodz, 90-436, Poland

RECRUITING

Novartis Investigative Site

Almada, 2805-267, Portugal

RECRUITING

Novartis Investigative Site

Braga, 4710243, Portugal

RECRUITING

Novartis Investigative Site

Coimbra, 3004-561, Portugal

RECRUITING

Novartis Investigative Site

Lisbon, 1169-050, Portugal

RECRUITING

Novartis Investigative Site

Lisbon, 1998-018, Portugal

RECRUITING

Novartis Investigative Site

Porto, 4099-001, Portugal

RECRUITING

Novartis Investigative Site

Bratislava, 811 09, Slovakia

RECRUITING

Novartis Investigative Site

Bratislava, 813 69, Slovakia

RECRUITING

Novartis Investigative Site

Prešov, 080 01, Slovakia

RECRUITING

Novartis Investigative Site

Trnava, 917 02, Slovakia

RECRUITING

Novartis Investigative Site

Raslouw Centurion, Gauteng, 0157, South Africa

RECRUITING

Novartis Investigative Site

Soweto, Gauteng, 2013, South Africa

RECRUITING

Novartis Investigative Site

Cape Town, 7505, South Africa

RECRUITING

Novartis Investigative Site

Durban, 4058, South Africa

RECRUITING

Novartis Investigative Site

Cadiz, Andalusia, 11009, Spain

RECRUITING

Novartis Investigative Site

Badalona, Barcelona, 08916, Spain

RECRUITING

Novartis Investigative Site

Sabadell, Barcelona, 08208, Spain

RECRUITING

Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

RECRUITING

Novartis Investigative Site

Manises, Valencia, 46940, Spain

RECRUITING

Novartis Investigative Site

Valencia, Valencia, 46017, Spain

RECRUITING

Novartis Investigative Site

Madrid, 28009, Spain

RECRUITING

Novartis Investigative Site

Madrid, 28046, Spain

RECRUITING

Novartis Investigative Site

Valencia, 46014, Spain

RECRUITING

Novartis Investigative Site

Basel, 4031, Switzerland

RECRUITING

Novartis Investigative Site

Bern, 3010, Switzerland

RECRUITING

Novartis Investigative Site

Zurich, 8091, Switzerland

RECRUITING

Novartis Investigative Site

Kaohsiung City, 83301, Taiwan

RECRUITING

Novartis Investigative Site

Taipei, 10002, Taiwan

RECRUITING

Novartis Investigative Site

Taoyuan District, 33305, Taiwan

RECRUITING

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

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

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): August 31, 2027
• Study Completion (Estimated): January 18, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

MY (6); AR (4); ZA (4); SL (4); PL (3); TW (3); CN (12); AU (5); DK (2); IT (11); BU (3); PT (6); CH (3); GR (3); ES (9); CA (6); US (36); ME (4); CO (4); DE (17)