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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

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

Key facts

Study ID

NCT06685835

Run by

Insmed Incorporated

People needed

214

Starts

2024-12-16

Expected to finish

2026-06-08

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• a. 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.

Where it is running

• USA007 — Sacramento, California, United States
• USA026 — Coral Gables, Florida, United States
• USA027 — Hollywood, Florida, United States
• USA021 — Margate, Florida, United States
• USA018 — Miami, Florida, United States
• USA025 — Ocala, Florida, United States
• USA004 — Tampa, Florida, United States
• USA010 — Weston, Florida, United States
• USA028 — Atlanta, Georgia, United States
• USA011 — Sandy Springs, Georgia, United States
• USA003 — Plainfield, Indiana, United States
• USA002 — Baton Rouge, Louisiana, United States
• USA017 — Boston, Massachusetts, United States
• USA012 — Detroit, Michigan, United States
• USA024 — Fort Gratiot, Michigan, United States
• USA020 — Minneapolis, Minnesota, United States
• USA015 — St Louis, Missouri, United States
• USA013 — Lebanon, New Hampshire, United States
• USA009 — Cleveland, Ohio, United States
• USA016 — Springfield, Ohio, United States
• USA019 — Hershey, Pennsylvania, United States
• USA022 — Philadelphia, Pennsylvania, United States
• USA005 — Dallas, Texas, United States
• USA023 — Dallas, Texas, United States
• USA001 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.