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.
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CABA,C1012aay,Argentina
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Caba,C1205aao,Argentina
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Linz,4020,Austria
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Leuven,3000,Belgium
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Liège,4000,Belgium
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Québec,Quebec,J1g 1x9,Canada
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London,Ontario,N6h 5l5,Canada
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Montreal,Quebec,H1y 3l1,Canada
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Edmonton,Alberta,T6g 1c3,Canada
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Karlovy Vary,Czech Republic,360 66,Czechia
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Prague,Czech Republic,180 00,Czechia
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Plzen Bolevec,32300,Czechia
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Prague,100 34,Czechia
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Prague,120 00,Czechia
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Prague,128 08,Czechia
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Prague,150 06,Czechia
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Brest,29609,France
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La Rochelle,17019,France
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Lyon,69003,France
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Nice,06000,France
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Reims,51100,France
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Rouen,76031,France
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Toulouse,31400,France
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Freiburg im Breisgau,79106,Germany
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Leipzig,Saxony,04103,Germany
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Bad Bentheim,48455,Germany
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Düsseldorf,40225,Germany
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Essen,45147,Germany
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Hamburg,20246,Germany
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Minden,32429,Germany
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Tübingen,72076,Germany
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Würzburg,97080,Germany
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Merzig,Saarland,66663,Germany
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Dessau,06847,Germany
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Dortmund,44137,Germany
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Lübeck,23538,Germany
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München,80377,Germany
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Thessaloniki,GR,564 03,Greece
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Pécs,7623,Hungary
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Debrecen,4032,Hungary
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Kecskemét,6001,Hungary
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Szeged,6720,Hungary
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Ipoh,Perak,30450,Malaysia
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Kota Kinabalu,Sabah,88586,Malaysia
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Johor Bahru,80100,Malaysia
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Selangor Darul Ehsan,68100,Malaysia
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Warsaw,02-953,Poland
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Warsaw,02-507,Poland
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Warsaw,02-962,Poland
Alma Cruz-Santana Private Practice
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Carolina,00985,Puerto Rico
Alma Cruz
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Bucharest,District 2,020125,Romania
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Bucharest,District 2,020762,Romania
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Pontevedra,36003,Spain
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Palma de Mallorca,Balearic Islands,07120,Spain
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Granollers,08402,Spain
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Madrid,28006,Spain
Austin Inst for Clinical Research
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Pflugerville,Texas,78660,United States
Edward Lain
Total Skin and Beauty Dermatology Center PC
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Birmingham,Alabama,35205,United States
Andria Thigpen
Rajini Murthy
Ctr for Dermatology Clinical Res
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Fremont,California,95438,United States
Sunil Dhawan
Endeavor Health
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Glenview,Illinois,60077,United States
Jalen Corey
Shannon Ewing
Southern IN Clinical Trials
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New Albany,Indiana,47150,United States
Megan Landis
Misty Humphress
Skin Specialists PC
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Omaha,Nebraska,68144,United States
Joel Schlessinger
Rivergate Dermatology and Skin Care Center
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Goodlettsville,Tennessee,37072-2301,United States
Keith H Loven
Accurate Clinical Research
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Humble,Texas,77346,United States
Chinelo Fangtang
Irene Noblitt
Care Access Alexandria
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Arlington,Virginia,22206,United States
David Bray
Lakeesha Kosh
Complexions Dermatology
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Danville,Virginia,24541,United States
Janaya Patron
Keith Robinson
Ctr Dermatology and Plastic Surgery
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Scottsdale,Arizona,85260,United States
Kenneth Steil
Stephen Fuller
USC Keck School of Medicine
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Los Angeles,California,90033,United States
Claire Chung
Katrina Lee
Floridian Research Institute
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Miami,Florida,33179,United States
Gretel Trullenque
Patricia Pareja
Metro Boston Clinical Partners
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Brighton,Massachusetts,02135,United States
Mark Amster
Clinical Research Inst of MI
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Chesterfield,Michigan,48047,United States
Karie Simons
Natalia Filipof
Vivida Dermatology
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Las Vegas,Nevada,89148,United States
Victoria Farley
North Shore University Hospital
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New Hyde Park,New York,11040,United States
Amit Garg
Cameron Dermatology
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New York,New York,10023,United States
Megha Singh
Michael Cameron
Ohio State University
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Columbus,Ohio,43210,United States
Jessica Kaffenberger
Apex Clinical Research Center LLC
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Mayfield Heights,Ohio,44124,United States
Jorge Garcia-Zuazaga
Stacey Spigiel
Clinical Research Ctr of Carolinas
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Charleston,South Carolina,29407,United States
Todd Schlesinger
Center for Clinical Studies-Lee
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Webster,Texas,77598,United States
Patricia C Lee
Forefront Dermatology
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Vienna,Virginia,22182,United States
Gianna Riley
Naiem Issa
CTT Research
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Gilbert,Arizona,85234,United States
Lori Kuuipo Eiko Ramirez
Driven Research
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Coral Gables,Florida,33134,United States
Emma Fuentez
Javier Alonso Llamazares
Emory School of Med Dermatology
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Atlanta,Georgia,30303,United States
Kimwanna Norwood
Lauren Orenstein
Dundee Dermatology
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West Dundee,Illinois,60118,United States
Paul Getz
Optima Research Boardman
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Boardman,Ohio,44512,United States
Hannah Titus
Patrick Shannon
Sarasota Arthritis Res Ctr
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Sarasota,Florida,34239,United States
Jesse Boodoo
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