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)
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)
Proportion of participants with Hidradenitis Suppurativa clinical response 50 (HiSCR50) at Week 16 — 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.
Trial sites (139)
Facility
City
Region
Status
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.
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.
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