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

Description

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

Conditions

Hidradenitis Suppurativa

Study Overview

Study Details

Study overview

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

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

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

Condition
Hidradenitis Suppurativa
Intervention / Treatment

-

Contacts and Locations

Baton Rouge

USA002, Baton Rouge, Louisiana, United States, 70809-2725

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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
  • * 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Insmed Incorporated,

Study Record Dates

2027-01-28