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Clinical Trials in China / NCT06799000
Active, not recruiting Phase 3

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 · tracked via the Priya Life Science China tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2025-01-31
Last updated
2026-08-20

Condition(s) studied

Hidradenitis Suppurativa

Investigational drug(s) / intervention(s)

Remibrutinib Dose ARemibrutinib Dose BPlacebo 1Placebo 2

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)

Study 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).

Eligibility

Sex
ALL
Min age
12 Years
Max age
100 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (139)

FacilityCityRegionStatus
Medical Dermatology Specialists Phoenix Arizona
Johnson Dermatology Fort Smith Arkansas
Arkansas Research Trials North Little Rock Arkansas
Cheryl Effron MD Inc Anaheim California
Physioseq Sacramento California
Olive View UCLA Medical Center Sylmar California
Clinical Trials Research Institute Thousand Oaks California
Howard University College of Medicine Washington D.C. District of Columbia
Florida Academic Centers Research and Education LLC Coral Gables Florida
University of MiamiHealth System Miami Florida
Ziaderm Research LLC North Miami Beach Florida
Revival Research Institute LLC Evans Georgia
Gwinnett Clinical Research Center Snellville Georgia
Immunology-Rheumatology Research Suwanee Georgia
Illinois Dermatology Institute Chicago Illinois
Dawes Fretzin Clinical Rea Group Indianapolis Indiana
Equity Medical LLC Bowling Green Kentucky
Dermat. and Adv. Aesthetics Lake Charles Louisiana
Michigan Center for Rsrch Company Clarkston Michigan
Henry Ford Hospital Detroit Michigan
Revival Research Institute Troy Michigan
University of Mississippi Med Ctr Jackson Mississippi
Care Access Hoboken Hoboken New Jersey
Forest Hills Dermatology Group New York New York
Icahn School Of Med At Mount Sinai New York New York
Skinsearch of Rochester Inc Rochester New York
OnSite Clinical Solutions LLC Huntersville North Carolina
Wake Forest Baptist Health Winston-Salem North Carolina
Unity Clinical Research Oklahoma City Oklahoma
Essential Medical Research Tulsa Oklahoma
UP Medical Center H System Pittsburgh Pennsylvania
Medical University of South Carolina MUSC Charleston South Carolina
Advanced Research Experts Nashville Tennessee
Bellaire Dermatology Associates Bellaire Texas
RFSA Dermatology San Antonio Texas
Virginia Clinical Research Norfolk Virginia
Novartis Investigative Site Caba Buenos Aires
Novartis Investigative Site CABA Buenos Aires
Novartis Investigative Site Rosario Santa Fe Province
Novartis Investigative Site CABA Argentina

+ 99 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06799000 on ClinicalTrials.gov ↗ ← All trials in China