Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Adult male or female participants ≥ 18 to ≤ 80 years of age.
  • Diagnosis of HS (confirmed by a dermatologist[EA1] ), 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.
  • PPD, CTM: since some PIs are not a dermatologist, wouldn`t this part limit the enrollment? Aren`t the physicians able to diagnose HS based on the diagnosis criteria (with documented medical records of 6 months)?Alternatively, sites could request the dermatologists` records from the patients.

Exclusion Criteria: 

  • Draining tunnel count of ≥ 20 at the Baseline Visit.
  • Other active skin disease or condition that could interfere with HS assessments (eg, infectious or other such as cutaneous Crohn’s disease).
  • Received systemic (intravenous or PO) antibiotic therapy within 8 weeks before the Baseline Visit.
    • PO doxycycline or minocycline up to 100 mg PO twice daily is permitted provided the dosing regimen has been 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-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) with potential therapeutic impact for HS within 4 weeks before the Baseline Visit.
  • Received any immunomodulatory agents within 4 weeks before the Baseline Visit.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 7/18/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Aaron Mangold, M.D.

Contact us for the latest status

Contact information:

Hannah Samuel Gnanadas

(480) 342-2906

SamuelGnanadas.Hannah@mayo.edu

More information

Publications

Publications are currently not available