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Clinical Trials in Germany / NCT06840392
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

NCT06840392 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2025-03-20
Last updated
2026-08-21

Condition(s) studied

Hidradenitis Suppurativa

Investigational drug(s) / intervention(s)

Remibrutinib Dose A →Remibrutinib Dose B →Placebo 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 (130)

FacilityCityRegionStatus
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.

More Novartis Pharmaceuticals trials in Germany

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 NCT06840392 on ClinicalTrials.gov ↗ ← All trials in Germany