A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)
Фаза 2 – изследване на ефективността и дозировката
Заболявания:
Hidradenitis Suppurativa
Спонсор: Insmed Incorporated
Налично на:
БГ
Обобщение
The primary purpose of the study is to evaluate the effect of brensocatib compared with placebo.
Кой може да участва
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.