Phase
Condition
Rosacea
Scalp Disorders
Hidradenitis Suppurativa
Treatment
Placebo 2
Placebo 1
Remibrutinib Dose B
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Male and female participants ≥ 18 years of age at the time of signing of theinformed consent.
Diagnosis of HS based on clinical history and physical examination for at least 6months prior to the Baseline visit.
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
Key Exclusion Criteria:
Presence of more than 20 fistulae/tunnels (both draining and non-draining) in totalat baseline.
Any active skin disease or conditions that may interfere with the assessment of HS.
Previous exposure to remibrutinib or other BTK inhibitors.
Use of other investigational drugs within 5 half-lives of enrollment, or within 30days (for small molecules) prior to randomization, or until the pharmacodynamiceffect has returned to baseline (for biologics), whichever is longer.
Significant bleeding risk or coagulation disorders.
History of gastrointestinal bleeding.
Requirement for anti-platelet (except for acetylsalicylic acid up to 100 mg/d orclopidogrel up to 75 mg/d) or anti-coagulant medication.
History or current hepatic disease.
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 ofthe study results or otherwise preclude participation or protocol adherence of theparticipant.
History of hypersensitivity to any of the study drug constituents.
Known or suspected infectious disease that is active, chronic or recurrent whichprecludes the participant from participating in the trial as per investigator'sassessment. These infectious diseases include and are not limited to opportunisticinfections (e.g., tuberculosis, atypical mycobacterioses, listeriosis oraspergillosis) and/or known or suspected Human Immunodeficiency Virus (HIV)infection. Should it be required by local regulations and/or considered appropriateby the investigator, an HIV test can be performed to confirm eligibility.
History of live attenuated vaccine administration within 6 weeks prior torandomization or requirement to receive these vaccinations at any time while onstudy treatment.
Major surgery within 8 weeks prior to screening or planned surgery for the durationof the study.
Other protocol-defined inclusion/exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Caba, C1012AAY
ArgentinaActive - Recruiting
Novartis Investigative Site
London, Ontario N6H 5L5
CanadaActive - Recruiting
Novartis Investigative Site
Montreal, Quebec H1Y 3L1
CanadaActive - Recruiting
Novartis Investigative Site
Sherbrooke, Quebec J1G 1X9
CanadaActive - Recruiting
Novartis Investigative Site
Quebec, J1G 1X9
CanadaActive - Recruiting
Novartis Investigative Site
Ipoh, Perak 30450
MalaysiaActive - Recruiting
Novartis Investigative Site
Kota Kinabalu, Sabah 88586
MalaysiaActive - Recruiting
Novartis Investigative Site
Wilayah Persekutuan, 62502
MalaysiaActive - Recruiting
Total Skin and Beauty Dermatology Center PC
Birmingham, Alabama 35205
United StatesActive - Recruiting
Ctr Dermatology and Plastic Surgery
Scottsdale, Arizona 85260
United StatesActive - Recruiting
Ctr for Dermatology Clinical Res
Fremont, California 95438
United StatesActive - Recruiting
USC Keck School of Medicine
Los Angeles, California 90033
United StatesActive - Recruiting
Floridian Research Institute
Miami, Florida 33179
United StatesActive - Recruiting
Grady Hospital Corporation
Atlanta, Georgia 30303
United StatesActive - Recruiting
Endeavor Health
Glenview, Illinois 60077
United StatesActive - Recruiting
Southern IN Clinical Trials
New Albany, Indiana 47150
United StatesActive - Recruiting
Metro Boston Clinical Partners
Brighton, Massachusetts 02135
United StatesActive - Recruiting
Clinical Research Inst of MI
Chesterfield, Michigan 48047
United StatesActive - Recruiting
Skin Specialists PC
Omaha, Nebraska 68144
United StatesActive - Recruiting
Vivida Dermatology
Las Vegas, Nevada 89148
United StatesActive - Recruiting
North Shore University Hospital
New Hyde Park, New York 11040
United StatesActive - Recruiting
Cameron Dermatology
New York, New York 10023
United StatesActive - Recruiting
Optima Dermatology Research
Boardman, Ohio 44512
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43210
United StatesActive - Recruiting
Wright State University
Fairborn, Ohio 45324
United StatesActive - Recruiting
Apex Clinical Research Center LLC
Mayfield Heights, Ohio 44124
United StatesActive - Recruiting
Clinical Research Ctr of Carolinas
Charleston, South Carolina 29407
United StatesActive - Recruiting
Rivergate Dermatology and Skin Care Center
Goodlettsville, Tennessee 37072-2301
United StatesActive - Recruiting
Accurate Clinical Research
Humble, Texas 77346
United StatesActive - Recruiting
Austin Inst for Clinical Research
Pflugerville, Texas 78660
United StatesActive - Recruiting
Center for Clinical Studies-Lee
Webster, Texas 77598
United StatesActive - Recruiting
Care Access Alexandria
Arlington, Virginia 22206
United StatesActive - Recruiting
Complexions Dermatology
Danville, Virginia 24541
United StatesActive - Recruiting
Forefront Dermatology
Vienna, Virginia 22182
United StatesActive - Recruiting
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