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Активно (без набиране) Фаза 2 NCT06685835

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.
Места на провеждане 10
Австралия (1)
AUS003
Darlinghurst , New South Wales
България (1)
BGR001
Lovech
Канада (1)
CAN003
Barrie , Ontario
Франция (1)
FRA001
Lyon , Auvergne-Rhône-Alpes
Германия (1)
DEU007
Langenau , Baden-Wurttemberg
Гърция (1)
GRC002
Athens , Attica
Нидерландия (1)
NLD001
Rotterdam
Полша (1)
POL006
Wroclaw , Lower Silesian Voivodeship
Испания (1)
ESP006
Badalona , Barcelona
САЩ (1)
USA001
Phoenix , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
16.12.2024
Крайна дата
17.11.2026
Регистрационен номер
NCT06685835
Източник
anzctr
Запитване за медицински туризъм

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