A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
NCT ID: NCT06840392
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
555 participants
INTERVENTIONAL
2025-03-20
2028-03-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Remibrutinib Dose A (Treatment Period 1 and 2)
articipants randomized to receive remibrutinib Dose A during Treatment Period 1 and 2
Remibrutinib Dose A
Remibrutinib Dose A (oral)
Remibrutinib Dose B (Treatment Period 1 and 2)
Participants randomized to receive remibrutinib Dose B during Treatment Period 1 and 2
Remibrutinib Dose B
Remibrutinib Dose B (oral)
Placebo (Treatment Period 1) + remibrutinib Dose B (Treatment Period 2)
Participants randomized to receive placebo during Treatment Period 1 followed by remibrutinib dose B during Treatment Period 2
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)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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)
Exclusion Criteria
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.
12 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Total Skin and Beauty Dermatology Center PC
Birmingham, Alabama, United States
CTT Research
Gilbert, Arizona, United States
Ctr Dermatology and Plastic Surgery
Scottsdale, Arizona, United States
Ctr for Dermatology Clinical Res
Fremont, California, United States
USC Keck School of Medicine
Los Angeles, California, United States
MedDerm Associates
San Diego, California, United States
Driven Research
Coral Gables, Florida, United States
Floridian Research Institute
Miami, Florida, United States
Sarasota Arthritis Res Ctr
Sarasota, Florida, United States
University Of South Florida
Tampa, Florida, United States
Emory School of Med Dermatology
Atlanta, Georgia, United States
Atlanta Biomedical Clin Res LLC
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Endeavor Health
Glenview, Illinois, United States
Dundee Dermatology
West Dundee, Illinois, United States
Southern IN Clinical Trials
New Albany, Indiana, United States
Beth Israel Deaconess Med Center
Boston, Massachusetts, United States
Metro Boston Clinical Partners
Brighton, Massachusetts, United States
Clinical Research Inst of MI
Chesterfield, Michigan, United States
Deluxe Dermatology
St Louis, Missouri, United States
Skin Specialists PC
Omaha, Nebraska, United States
Vivida Dermatology
Las Vegas, Nevada, United States
North Shore University Hospital
New Hyde Park, New York, United States
Cameron Dermatology
New York, New York, United States
Optima Research Boardman
Boardman, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Wright State University
Fairborn, Ohio, United States
Apex Clinical Research Center LLC
Mayfield Heights, Ohio, United States
Clinical Research Ctr of Carolinas
Charleston, South Carolina, United States
Goodlettsville Dermatology Research
Goodlettsville, Tennessee, United States
Accurate Clinical Research
Humble, Texas, United States
Austin Inst for Clinical Research
Pflugerville, Texas, United States
Center for Clinical Studies-Lee
Webster, Texas, United States
Care Access Alexandria
Arlington, Virginia, United States
Complexions Dermatology
Danville, Virginia, United States
Forefront Dermatology
Vienna, Virginia, United States
Novartis Investigative Site
Berazategui, Buenos Aires, Argentina
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CABA, , Argentina
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Caba, , Argentina
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Córdoba, , Argentina
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Linz, , Austria
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Brussels, Brussels Capital, Belgium
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Woluwe-Saint-Lambert, Brussels Capital, Belgium
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Leuven, Vlaams Brabant, Belgium
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Liège, , Belgium
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Edmonton, Alberta, Canada
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London, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Medellín, Antioquia, Colombia
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Bogota, Cundinamarca, Colombia
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Bogota, Cundinamarca, Colombia
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Medellín, , Colombia
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Karlovy Vary, , Czechia
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Plzen Bolevec, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Brest, , France
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La Rochelle, , France
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Lyon, , France
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Nice, , France
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Reims, , France
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Rouen, , France
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Toulouse, , France
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Würzburg, Bavaria, Germany
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Frankfurt am Main, Hesse, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Merzig, Saarland, Germany
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Leipzig, Saxony, Germany
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Bad Bentheim, , Germany
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Berlin, , Germany
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Dessau, , Germany
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Dortmund, , Germany
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Essen, , Germany
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Hamburg, , Germany
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Lübeck, , Germany
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Minden, , Germany
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München, , Germany
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Tübingen, , Germany
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Athens, , Greece
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Chaïdári, , Greece
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Thessaloniki, , Greece
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Pécs, Baranya, Hungary
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Debrecen, Hajdu Bihar Megye, Hungary
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Debrecen, Hajdú-Bihar, Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Kecskemét, , Hungary
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Szeged, , Hungary
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Kuala Lumpur, Kuala Lumpur, Malaysia
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Ipoh, Perak, Malaysia
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Kota Kinabalu, Sabah, Malaysia
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Johor Bahru, , Malaysia
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Selangor Darul Ehsan, , Malaysia
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Wilayah Persekutuan, , Malaysia
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Durango, , Mexico
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Warsaw, Masovian Voivodeship, Poland
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Warsaw, , Poland
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Warsaw, , Poland
Alma Cruz-Santana Private Practice
Carolina, , Puerto Rico
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Bucharest, District 2, Romania
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Bucharest, District 2, Romania
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Bucharest, , Romania
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Timișoara, , Romania
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Granada, Andalusia, Spain
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Palma, Balearic Islands, Spain
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Barcelona, , Spain
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Granollers, , Spain
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Las Palmas GC, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Pontevedra, , Spain
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Seville, , Spain
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Valencia, , Spain
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Izmir, Balcova, Turkey (Türkiye)
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Ankara, Bilkent-Cankaya, Turkey (Türkiye)
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Izmir, Buca, Turkey (Türkiye)
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Aydin, Efeler, Turkey (Türkiye)
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Denizli, Kinikli, Turkey (Türkiye)
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Ankara, Sihhiye-Altindag, Turkey (Türkiye)
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Ankara, Yenimahalle, Turkey (Türkiye)
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Mersin, Yenisehir, Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Kecioren Ankara, , Turkey (Türkiye)
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Leeds, West Yorkshire, United Kingdom
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Cardiff, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Southampton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-513266-19-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CLOU064J12302
Identifier Type: -
Identifier Source: org_study_id
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