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A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)

A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)

Not Recruiting
18-80 years
All
Phase 2

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Overview

The primary purpose of the study is evaluate the effect of brensocatib compared with placebo.

Eligibility

Inclusion Criteria:

  • Diagnosis of HS (confirmed by a dermatologist), with a history of signs and symptoms consistent with HS for at least 6 months before the Screening Visit.
  • Moderate or severe HS defined as a total of ≥6 inflammatory lesions (inflammatory nodules and/or abscesses) for at least 8 weeks before the Baseline Visit.
  • HS lesions in at least 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline Visits.

Exclusion Criteria:

  • Draining tunnel count of ≥20 at the Baseline Visit.
  • Surgical or laser intervention for an HS lesion during the Screening Period.
  • Clinical diagnosis of Papillon-Lefèvre Syndrome.
  • Participants with an absolute neutrophil count <1,000/mm3 at the Screening Visit.
  • Participants having active liver disease or hepatic dysfunction.
  • Have diagnosed periodontal disease under active management by a dentist or expected to have periodontal disease-related procedures within the study period.
  • Received systemic (intravenous or orally [PO]) antibiotic therapy within 8 weeks before the Baseline Visit
    1. Doxycycline or minocycline up to 100 mg twice daily is permitted provided the dosing regimen being stable for at least 8 weeks before the Baseline Visit and is expected to continue.
  • Received PO or transdermal opioid analgesics (except tramadol) for any reason within

    4 weeks before the Baseline Visit.

  • Permitted analgesics for HS-related pain have not been at a stable dose regimen for at least 4 weeks before the Baseline Visit.
  • Received prescription topical therapies for the treatment of HS within 2 weeks before the Baseline Visit.
  • Received any anti-tumor necrosis factor (TNF)-α/other biologics treatment within 12 weeks or 5 elimination half-lives, whichever is longer, before the Baseline Visit.
  • Received systemic nonbiologic therapies (eg, corticosteroids and retinoids) for HS within 4 weeks before the Baseline Visit.
  • Received any immunomodulatory agents within 4 weeks before the Baseline Visit.

Note: Other Inclusion/Exclusion criteria may apply.

Study details
    Hidradenitis Suppurativa

NCT06685835

Insmed Incorporated

12 December 2025

FAQs

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