Efficacy and Safety of HS-10374 Compared to Placebo in Adults With Active Psoriatic Arthritis

Официальное название

A Randomized, Double-blind, Placebo- and Comparator-controlled, Multicenter, Phase 2 Trial to Assess the Efficacy and Safety of HS-10374 in Adults With Active Psoriatic Arthritis

Обзор

This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of active psoriatic arthritis. Additionally, this study is to find the optimal dosing for the future clinical development of HS-10374.

Вмешательства

• Препарат HS-10374
  Administered orally QD for 16 weeks
• Препарат HS-10374-matched placebo tablets
  Administered orally QD for 16 weeks
• Препарат Tofacitinib 5Mg Tab,Oral
  Administered orally BID for 16 weeks

Первичные конечные точки

• Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20) response at Week 16 [Срок оценки: At week 16]

Вторичные конечные точки (12)

• Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20) response at Week 12 [Срок оценки: At week 12]
• Proportion of participants meeting American College of Rheumatology improvement of 50% (ACR50) response at Week 16 [Срок оценки: At week 16]
• Proportion of participants meeting American College of Rheumatology improvement of 70% (ACR70) response at Week 16 [Срок оценки: At week 16]
• Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score at week 16 [Срок оценки: At week 16]
• Proportion of participants meeting Psoriasis Area and Severity Index (PASI) 75/90 responses at week 16 [Срок оценки: At week 16]
• Proportion of participants meeting Static physician's global assessment (sPGA) 0/1 score at week 16 [Срок оценки: At week 16]
• Change from baseline in Psoriasis body surface area (BSA) at week 16 [Срок оценки: At week 16]
• Change from baseline in the dermatology life quality index (DLQI) scores at week 16 [Срок оценки: At week 16]
• Change from baseline in Disease Activity Score 28 with C-reactive protein (DAS28-CRP) score at week 16 [Срок оценки: At week 16]
• Change from baseline in the Disease Activity Index for Psoriatic Arthritis Score (DAPSA) at week 16 [Срок оценки: At week 16]
• Proportion of participants meeting Minimal Disease Activity (MDA) response at week 16 [Срок оценки: At week 16]
• Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at week 16 [Срок оценки: At week 16]

Критерии участия

Критерии включения

• Male or female subjects between the ages of 18-75 years.
• Has a history of psoriatic arthritis (PsA) for at least 6 months, and meets the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening.
• Active arthritis as shown ≥ 3 swollen joints (66 joints) and ≥ 3 tender joints (68 joints) at both screening and baseline.
• Active plague psoriatic skin lesion or documented history of plague psoriatic at screening.
• hs-CRP ≥ 3mg/L at screening.
• Subjects either (i) do not have prior exposure to biologics (biologic-naïve) or (ii) have failed or been intolerant to 1 TNF-inhibitor (TNFi-experienced).

Критерии исключения

• Non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-induced psoriasis), with the exception of nail psoriasis, which is allowed.
• Other autoimmune or autoinflammatory condition ( ie, rheumatoid arthritis, systemic lupus erythematous, gout), with the exception of inflammatory bowel disease and/or autoimmune uveitis being inactive at least 12 months before the screening, as assessed by the investigator.
• Active fibromyalgia syndrome
• Recent history of active infection, chronic infection history or risk of serious infection.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Huashan Hospital affiliated to Fudan University — Шанхай

Идентификаторы

NCT: NCT06176508 · HS-10374-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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