Assessing the effects of remibrutinib on moderate to severe hidradenitis suppurativa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy, safety, and tolerability of remibrutinib, a Bruton's tyrosine kinase inhibitor, in adults with moderate to severe hidradenitis suppurativa (HS). The study spans 76 weeks, including a 16-week double-blind treatment phase with either remibrutinib or placebo, followed by a 52-week treatment phase with remibrutinib. Participants who discontinue treatment are encouraged to remain in the study for safety follow-up. The trial aims to provide insights into the clinical response of HS to this new treatment.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. 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)

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.

Where it's running

• Total Skin and Beauty Dermatology Center PC
  Birmingham, Alabama, United States Recruiting
• CTT Research
  Gilbert, Arizona, United States Recruiting
• Ctr Dermatology and Plastic Surgery
  Scottsdale, Arizona, United States Recruiting
• Ctr for Dermatology Clinical Res
  Fremont, California, United States Recruiting
• USC Keck School of Medicine
  Los Angeles, California, United States Recruiting
• MedDerm Associates
  San Diego, California, United States Recruiting

+88 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BTK inhibitor remibrutinib in hidradenitis suppurativa shows how it works in adults

  This phase 1 trial tests whether remibrutinib can safely affect HS in adults with moderate to severe disease.

  Recruiting at 2 sites Phase 1 Novartis · San Diego, California and 1 other locations · NCT07855276

• Remibrutinib extension study for adults with moderate to severe hidradenitis suppurativa

  This extension study tests whether continuing remibrutinib is safe and helps skin symptoms in adults who completed prior HS trials.

  Recruiting at 61 sites Phase 3 Novartis · Birmingham, Alabama and 60 other locations · NCT07665437

• Olatorepatide vs placebo for adults with moderate-to-severe hidradenitis suppurativa who are overweight

  This study tests whether olatorepatide can help people with hidradenitis suppurativa who are overweight or obese.

  Recruiting Phase 2 Regeneron Pharmaceuticals · The Bronx, New York · NCT07830329

• Remibrutinib and omalizumab-based treatment approach for adults with chronic spontaneous urticaria not well controlled by antihistamines

  This trial tests a sequencing plan using remibrutinib and omalizumab to see if it helps adults with chronic spontaneous urticaria that isn’t well controlled by second-generation antihistamines.

  Recruiting at 10 sites Phase 3 Novartis · London, Ontario and 9 other locations · NCT07816328

• Remibrutinib for Severe Chronic Pruritus of Unknown Origin in Adults

  We’re testing whether remibrutinib can help adults with severe, unexplained itching that hasn’t gone away with moisturizers.

  Recruiting at 12 sites Phase 3 Novartis · Fremont, California and 11 other locations · NCT07811869

• Remibrutinib for IgE-mediated peanut, milk, and egg allergy

  This study tests whether remibrutinib can help people with peanut, milk, or egg allergies by comparing it to placebo over 52 weeks.

  Recruiting at 22 sites Phase 3 Novartis · Birmingham, Alabama and 21 other locations · NCT07768371

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.