A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
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 (130)
Facility
City
Region
Status
Total Skin and Beauty Dermatology Center PC
Birmingham
Alabama
CTT Research
Gilbert
Arizona
Ctr for Dermatology Clinical Res
Fremont
California
USC Keck School of Medicine
Los Angeles
California
MedDerm Associates
San Diego
California
Driven Research
Miami
Florida
Floridian Research Institute
Miami
Florida
Sarasota Arthritis Res Ctr
Sarasota
Florida
University Of South Florida
Tampa
Florida
Emory School of Med Dermatology
Atlanta
Georgia
Atlanta Biomedical Clin Res LLC
Atlanta
Georgia
Northwestern University
Chicago
Illinois
Endeavor Health
Glenview
Illinois
Dundee Dermatology
West Dundee
Illinois
Southern IN Clinical Trials
New Albany
Indiana
Beth Israel Deaconess Med Center
Boston
Massachusetts
Metro Boston Clinical Partners
Brighton
Massachusetts
Clinical Research Inst of MI
Chesterfield
Michigan
Deluxe Dermatology
St Louis
Missouri
Skin Specialists PC
Omaha
Nebraska
Vivida Dermatology
Las Vegas
Nevada
North Shore University Hospital
New Hyde Park
New York
Cameron Dermatology
New York
New York
Optima Research Boardman
Boardman
Ohio
Ohio State University
Columbus
Ohio
Wright State University
Fairborn
Ohio
Apex Clinical Research Center LLC
Mayfield Heights
Ohio
Clinical Research Ctr of Carolinas
Charleston
South Carolina
Goodlettsville Dermatology Research
Goodlettsville
Tennessee
Accurate Clinical Research
Humble
Texas
Austin Inst for Clinical Research
Pflugerville
Texas
Center for Clinical Studies-Lee
Webster
Texas
Care Access Alexandria
Arlington
Virginia
Complexions Dermatology
Danville
Virginia
Forefront Dermatology
Vienna
Virginia
Novartis Investigative Site
Córdoba
Córdoba Province
Novartis Investigative Site
CABA
Argentina
Novartis Investigative Site
Caba
Argentina
Novartis Investigative Site
Linz
Austria
Novartis Investigative Site
Brussels
Brussels Capital
+ 90 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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