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

Launched by INSMED INCORPORATED · Nov 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called brensocatib for adults with moderate to severe Hidradenitis Suppurativa (HS), which is a painful skin condition that causes lumps and abscesses, often in areas like the armpits or groin. The goal is to see how well brensocatib works compared to a placebo, which is a dummy treatment. The trial is currently recruiting participants aged 18 to 75 who have been diagnosed with HS by a dermatologist and have had this condition for at least six months. To qualify, participants should have a certain number of active lesions and must have them in different areas of the body.

If you decide to participate, you will be monitored closely throughout the study, but there are some criteria that might prevent you from joining. For instance, if you have had recent surgeries for HS or specific health conditions, you may not be eligible. It’s important to note that this study aims to ensure safety, so certain medications and health issues could affect your participation. Overall, this trial offers a chance to explore a new treatment option for those struggling with HS while contributing to important medical research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 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 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.