A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
Purpose
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).
Condition
- Hidradenitis Suppurativa
Eligibility
- Eligible Ages
- Between 12 Years and 100 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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)
Exclusion Criteria
- 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Remibrutinib Dose A (Treatment Period 1 and 2) |
articipants randomized to receive remibrutinib Dose A during Treatment Period 1 and 2 |
|
|
Experimental Remibrutinib Dose B (Treatment Period 1 and 2) |
Participants randomized to receive remibrutinib Dose B during Treatment Period 1 and 2 |
|
|
Placebo Comparator 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 |
|
Recruiting Locations
Total Skin and Beauty Dermatology Center PC
Birmingham, Alabama 35205
Birmingham, Alabama 35205
CTT Research
Gilbert, Arizona 85234
Gilbert, Arizona 85234
Ctr Dermatology and Plastic Surgery
Scottsdale, Arizona 85260
Scottsdale, Arizona 85260
Ctr for Dermatology Clinical Res
Fremont, California 95438
Fremont, California 95438
USC Keck School of Medicine
Los Angeles, California 90033
Los Angeles, California 90033
MedDerm Associates
San Diego, California 92103
San Diego, California 92103
Driven Research
Coral Gables, Florida 33134
Coral Gables, Florida 33134
Floridian Research Institute
Miami, Florida 33179
Miami, Florida 33179
Sarasota Arthritis Res Ctr
Sarasota, Florida 34239
Sarasota, Florida 34239
Atlanta Biomedical Clin Res LLC
Atlanta, Georgia 30331
Atlanta, Georgia 30331
Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
Beth Israel Deaconess Med Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Metro Boston Clinical Partners
Brighton, Massachusetts 02135
Brighton, Massachusetts 02135
Clinical Research Inst of MI
Chesterfield, Michigan 48047
Chesterfield, Michigan 48047
Deluxe Dermatology
St Louis, Missouri 63117
St Louis, Missouri 63117
Skin Specialists PC
Omaha, Nebraska 68144
Omaha, Nebraska 68144
North Shore University Hospital
New Hyde Park, New York 11040
New Hyde Park, New York 11040
Ohio State University
Columbus, Ohio 43210
Columbus, Ohio 43210
Wright State University
Fairborn, Ohio 45324
Fairborn, Ohio 45324
Apex Clinical Research Center LLC
Mayfield Heights, Ohio 44124
Mayfield Heights, Ohio 44124
Clinical Research Ctr of Carolinas
Charleston, South Carolina 29407
Charleston, South Carolina 29407
Goodlettsville Dermatology Research
Goodlettsville, Tennessee 37072-2301
Goodlettsville, Tennessee 37072-2301
Accurate Clinical Research
Humble, Texas 77346
Humble, Texas 77346
Austin Inst for Clinical Research
Pflugerville, Texas 78660
Pflugerville, Texas 78660
Center for Clinical Studies-Lee
Webster, Texas 77598
Webster, Texas 77598
Complexions Dermatology
Danville, Virginia 24541
Danville, Virginia 24541
Alma Cruz-Santana Private Practice
Carolina, Puerto Rico 00985
Carolina, Puerto Rico 00985
More Details
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
Detailed Description
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.