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)
NCT ID: NCT06799000
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
555 participants
INTERVENTIONAL
2025-01-31
2028-02-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Remibrutinib Dose A (Treatment Period 1 and 2)
Participants randomized to receive remibrutinib Dose A during Treatment Period 1 and 2
Remibrutinib Dose A
Remibrutinib Dose A (oral)
Remibrutinib Dose B (Treatment Period 1 and 2)
Participants randomized to receive remibrutinib Dose B during Treatment Period 1 and 2
Remibrutinib Dose B
Remibrutinib Dose B (oral)
Placebo (Treatment Period 1) + remibrutinib Dose B (Treatment Period 2)
Participants randomized to receive placebo during Treatment Period 1 followed by remibrutinib dose B during Treatment Period 2
Remibrutinib Dose B
Remibrutinib Dose B (oral)
Placebo 1
Placebo matching to remibrutinib Dose A (oral)
Placebo 2
Placebo matching to remibrutinib Dose B (oral)
Interventions
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Remibrutinib Dose A
Remibrutinib Dose A (oral)
Remibrutinib Dose B
Remibrutinib Dose B (oral)
Placebo 1
Placebo matching to remibrutinib Dose A (oral)
Placebo 2
Placebo matching to remibrutinib Dose B (oral)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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)
Exclusion Criteria
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.
12 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
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CABA, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
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CABA, , Argentina
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Phillip, Australian Capital Territory, Australia
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Sydney, New South Wales, Australia
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Westmead, New South Wales, Australia
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Melbourne, Victoria, Australia
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Parkville, Victoria, Australia
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Sofia, Bulgaria, Bulgaria
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Stara Zagora, Bulgaria, Bulgaria
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Pleven, , Bulgaria
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Sofia, , Bulgaria
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Surrey, British Columbia, Canada
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St. John's, Newfoundland and Labrador, Canada
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Hamilton, Ontario, Canada
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Richmond Hill, Ontario, Canada
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Québec, Quebec, Canada
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Saint-Jérôme, Quebec, Canada
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Fuzhou, Fujian, China
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Guangzhou, Guangdong, China
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Wuhan, Hubei, China
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Changsha, Hunan, China
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Changchun, Jilin, China
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Shenyang, Liaoning, China
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Xian, Shanxi, China
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Chengdu, Sichuan, China
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Ürümqi, Xinjiang, China
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Ningbo, Zhejiang, China
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Beijing, , China
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Jinan, , China
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Barranquilla, Atlántico, Colombia
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Bogota, Cundinamarca, Colombia
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Cali, Valle del Cauca Department, Colombia
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Medellín, , Colombia
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Kobenhavn N V, , Denmark
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Roskilde, , Denmark
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Langenau, Baden-Wurttemberg, Germany
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Darmstadt, Hesse, Germany
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Dresden, Saxony, Germany
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Halle, Saxony-Anhalt, Germany
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Aachen, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bochum, , Germany
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Bonn, , Germany
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Erlangen, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Kiel, , Germany
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Mainz, , Germany
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Memmingen, , Germany
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Münster, , Germany
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Stade, , Germany
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Chaïdári, , Greece
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Heraklion Crete., , Greece
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Thessaloniki, , Greece
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Ancona, AN, Italy
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Brescia, BS, 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
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Muar town, Johor, Malaysia
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Kota Bharu, Kelantan, Malaysia
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George Town, Pulau Pinang, Malaysia
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Kuching, Sarawak, Malaysia
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Kuala Terengganu, Terengganu, Malaysia
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Kuala Lumpur, , Malaysia
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Cuauhtémoc, Mexico City, Mexico
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Chihuahua City, , Mexico
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Lodz, , Poland
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Almada, , Portugal
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Braga, , Portugal
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Coimbra, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Bratislava, Slovakia, Slovakia
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Trnava, Slovakia, Slovakia
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Bratislava, , Slovakia
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Prešov, , Slovakia
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Raslouw Centurion, Gauteng, South Africa
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Soweto, Gauteng, South Africa
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Cape Town, , South Africa
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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
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Manises, Valencia, Spain
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Valencia, Valencia, Spain
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Madrid, , Spain
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Madrid, , Spain
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Valencia, , Spain
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Basel, , Switzerland
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Bern, , Switzerland
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Zurich, , Switzerland
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Kaohsiung City, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-513282-39-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CLOU064J12301
Identifier Type: -
Identifier Source: org_study_id
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