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

Trial details

Who runs it

Insmed Incorporated

Trial code

NCT06685835EU 2024-515959-38-00

Record updated

29 June 2026

Original description

The primary purpose of the study is to evaluate the effect of brensocatib compared with placebo.Read full original descriptionShow less

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa - The CEDAR Study

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

Inclusion: 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: Surgical or laser intervention for an HS lesion during the Screening Period; Received systemic (intravenous or orally [PO]) antibiotic therapy within 8 weeks before the Baseline Visit; 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; Clinical diagnosis of Papillon-Lefèvre Syndrome; 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; Draining tunnel count of ≥20 at the Baseline Visit; Participants with an absolute neutrophil count <1,000/mm3 at the Screening Visit.

ClinicalTrials.gov NCT06685835 · EU CTIS 2024-515959-38-00