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Evaluating Brensocatib for Moderate to Severe Hidradenitis Suppurativa

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

PHASE2 · Insmed Incorporated · NCT06685835

This study is testing if a new medication called brensocatib can help adults with moderate to severe hidradenitis suppurativa feel better compared to a placebo.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment204 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorInsmed Incorporated (industry)
Locations54 sites (Sacramento, California and 53 other locations)
Trial IDNCT06685835 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of brensocatib in adults diagnosed with moderate to severe hidradenitis suppurativa (HS). Participants will receive either brensocatib or a placebo to determine the drug's effectiveness in reducing HS symptoms. The study focuses on individuals with a confirmed diagnosis of HS and a history of the condition for at least six months. The primary goal is to compare the outcomes between the treatment and placebo groups over a specified period.

Who should consider this trial

Good fit: Ideal candidates are adults with a confirmed diagnosis of moderate to severe hidradenitis suppurativa, characterized by multiple inflammatory lesions.

Not a fit: Patients with draining tunnels count of 20 or more, or those with certain comorbidities such as active liver disease, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from moderate to severe hidradenitis suppurativa.

How similar studies have performed: While there have been studies on hidradenitis suppurativa treatments, the specific approach of using brensocatib is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Diagnosis of HS (confirmed by a dermatologist), with a history of 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

  a. Doxycycline or minocycline 100 mg twice daily 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 this trial is running

Sacramento, California and 53 other locations

+4 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Hidradenitis Suppurativa, HS

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.