Study Description
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). The total duration of the study is 76 weeks and consists of: Screening (up to 4 weeks), Treatment Period 1 (16 weeks, double-blind treatment with remibrutinib (Dose A or Dose B) or placebo, Treatment Period 2 (52 weeks, treatment with remibrutinib (Dose A or Dose B) and Safety Follow-Up (treatment-free follow-up for 4 weeks).
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.
Interventions
Placebo 1
Placebo 2
Remibrutinib Dose A
Remibrutinib Dose B
Eligibility Criteria
Key Inclusion Criteria:
1. Male and female participants ≥ 18 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.
Novartis Investigative Site
Recruiting
Caba,C1012aay,Argentina
Novartis Investigative Site
Recruiting
London,Ontario,N6h 5l5,Canada
Novartis Investigative Site
Recruiting
Montreal,Quebec,H1y 3l1,Canada
Novartis Investigative Site
Recruiting
Quebec,J1g 1x9,Canada
Novartis Investigative Site
Recruiting
Ipoh,Perak,30450,Malaysia
Novartis Investigative Site
Recruiting
Kota Kinabalu,Sabah,88586,Malaysia
Novartis Investigative Site
Recruiting
Wilayah Persekutuan,62502,Malaysia
Complexions Dermatology
Recruiting
Danville,Virginia,24541,United States
Janaya Patron
Keith Robinson
Clinical Research Inst of MI
Recruiting
Chesterfield,Michigan,48047,United States
Natalia Filipof
Karie Simons
Clinical Research Ctr of Carolinas
Recruiting
Charleston,South Carolina,29407,United States
Todd Schlesinger
Rivergate Dermatology and Skin Care Center
Recruiting
Goodlettsville,Tennessee,37072-2301,United States
Keith H Loven
Floridian Research Institute
Recruiting
Miami,Florida,33179,United States
Gretel Trullenque
Yusmara Villa
Endeavor Health
Recruiting
Glenview,Illinois,60077,United States
Joseph Binder
Shannon Ewing
Ohio State University
Recruiting
Columbus,Ohio,43210,United States
Jessica Kaffenberger
Austin Inst for Clinical Research
Recruiting
Pflugerville,Texas,78660,United States
Edward Lain
Vivida Dermatology
Recruiting
Las Vegas,Nevada,89148,United States
Victoria Farley
Center for Clinical Studies-Lee
Recruiting
Webster,Texas,77598,United States
Patricia C Lee
North Shore University Hospital
Recruiting
New Hyde Park,New York,11040,United States
Amit Garg
Accurate Clinical Research
Recruiting
Humble,Texas,77346,United States
Chinelo Fangtang
Irene Noblitt
Grady Hospital Corporation
Recruiting
Atlanta,Georgia,30303,United States
Lauren Orenstein
Southern IN Clinical Trials
Recruiting
New Albany,Indiana,47150,United States
Christy Nardi
Megan Landis
Ctr Dermatology and Plastic Surgery
Recruiting
Scottsdale,Arizona,85260,United States
Kenneth Steil
Stephen Fuller
Total Skin and Beauty Dermatology Center PC
Recruiting
Birmingham,Alabama,35205,United States
Angela Powell
Rajini Murthy
Forefront Dermatology
Recruiting
Vienna,Virginia,22182,United States
Naiem Issa
Sophia Bortnick
Metro Boston Clinical Partners
Recruiting
Brighton,Massachusetts,02135,United States
Mark Amster
Apex Clinical Research Center LLC
Recruiting
Mayfield Heights,Ohio,44124,United States
Hannah Snyder
Jorge Garcia-Zuazaga
Cameron Dermatology
Recruiting
New York,New York,10023,United States
Jennie Mata
Michael Cameron
Care Access Alexandria
Recruiting
Arlington,Virginia,22206,United States
David Bray
Nicole Thornton
Skin Specialists PC
Recruiting
Omaha,Nebraska,68144,United States
Joel Schlessinger
USC Keck School of Medicine
Recruiting
Los Angeles,California,90033,United States
Katrina Lee
Raveena Ghanshani
Ctr for Dermatology Clinical Res
Recruiting
Fremont,California,95438,United States
Sunil Dhawan
Worldwide Contacts
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