Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult Patients With Moderate to Severe Hidradenitis Suppurativa

Last updated: May 5, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Rosacea

Scalp Disorders

Hidradenitis Suppurativa

Treatment

Placebo 2

Placebo 1

Remibrutinib Dose B

Clinical Study ID

NCT06840392
CLOU064J12302
2024-513266-19-00
  • Ages 18-100
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Male and female participants ≥ 18 years of age at the time of signing of theinformed consent.

  2. Diagnosis of HS based on clinical history and physical examination for at least 6months 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

Key Exclusion Criteria:

  1. Presence of more than 20 fistulae/tunnels (both draining and non-draining) in totalat 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 30days (for small molecules) prior to randomization, or until the pharmacodynamiceffect 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 orclopidogrel 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 ofthe study results or otherwise preclude participation or protocol adherence of theparticipant.

  10. History of hypersensitivity to any of the study drug constituents.

  11. 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.

  12. History of live attenuated vaccine administration within 6 weeks prior torandomization or requirement to receive these vaccinations at any time while onstudy treatment.

  13. 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

Total Participants: 555
Treatment Group(s): 4
Primary Treatment: Placebo 2
Phase: 3
Study Start date:
March 20, 2025
Estimated Completion Date:
October 20, 2028

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Caba, C1012AAY
    Argentina

    Active - Recruiting

  • Novartis Investigative Site

    London, Ontario N6H 5L5
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Montreal, Quebec H1Y 3L1
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Sherbrooke, Quebec J1G 1X9
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Quebec, J1G 1X9
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Ipoh, Perak 30450
    Malaysia

    Active - Recruiting

  • Novartis Investigative Site

    Kota Kinabalu, Sabah 88586
    Malaysia

    Active - Recruiting

  • Novartis Investigative Site

    Wilayah Persekutuan, 62502
    Malaysia

    Active - Recruiting

  • Total Skin and Beauty Dermatology Center PC

    Birmingham, Alabama 35205
    United States

    Active - Recruiting

  • Ctr Dermatology and Plastic Surgery

    Scottsdale, Arizona 85260
    United States

    Active - Recruiting

  • Ctr for Dermatology Clinical Res

    Fremont, California 95438
    United States

    Active - Recruiting

  • USC Keck School of Medicine

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Floridian Research Institute

    Miami, Florida 33179
    United States

    Active - Recruiting

  • Grady Hospital Corporation

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

  • Endeavor Health

    Glenview, Illinois 60077
    United States

    Active - Recruiting

  • Southern IN Clinical Trials

    New Albany, Indiana 47150
    United States

    Active - Recruiting

  • Metro Boston Clinical Partners

    Brighton, Massachusetts 02135
    United States

    Active - Recruiting

  • Clinical Research Inst of MI

    Chesterfield, Michigan 48047
    United States

    Active - Recruiting

  • Skin Specialists PC

    Omaha, Nebraska 68144
    United States

    Active - Recruiting

  • Vivida Dermatology

    Las Vegas, Nevada 89148
    United States

    Active - Recruiting

  • North Shore University Hospital

    New Hyde Park, New York 11040
    United States

    Active - Recruiting

  • Cameron Dermatology

    New York, New York 10023
    United States

    Active - Recruiting

  • Optima Dermatology Research

    Boardman, Ohio 44512
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Wright State University

    Fairborn, Ohio 45324
    United States

    Active - Recruiting

  • Apex Clinical Research Center LLC

    Mayfield Heights, Ohio 44124
    United States

    Active - Recruiting

  • Clinical Research Ctr of Carolinas

    Charleston, South Carolina 29407
    United States

    Active - Recruiting

  • Rivergate Dermatology and Skin Care Center

    Goodlettsville, Tennessee 37072-2301
    United States

    Active - Recruiting

  • Accurate Clinical Research

    Humble, Texas 77346
    United States

    Active - Recruiting

  • Austin Inst for Clinical Research

    Pflugerville, Texas 78660
    United States

    Active - Recruiting

  • Center for Clinical Studies-Lee

    Webster, Texas 77598
    United States

    Active - Recruiting

  • Care Access Alexandria

    Arlington, Virginia 22206
    United States

    Active - Recruiting

  • Complexions Dermatology

    Danville, Virginia 24541
    United States

    Active - Recruiting

  • Forefront Dermatology

    Vienna, Virginia 22182
    United States

    Active - Recruiting

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