A Study to Confirm Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis

Официальное название

A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HS-10374 in Adult Subjects With Moderate To Severe Plaque Psoriasis

Обзор

This study has been designed to confirm the clinical efficacy and safety of HS-10374 in the treatment of moderate to severe plaque psoriasis.

Подробное описание

This is a 52-week, multi-center, randomized, double-blind, placebo-controlled, Phase 3 study. The study duration includes a 4-week screening period, a 16-week placebo-controlled treatment period, a 36-week study drug treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned in a 2:1 ratio to receive HS-10374 or placebo QD. At Week 16, subjects receiving placebo will be switched to HS-10374 QD.

Вмешательства

• Препарат HS-10374 6mg tablets
  Specified dose of HS-10374 tablets administered orally QD on specified days
• Препарат HS-10374-matched placebo tablets
  Specified dose of HS-10374-matched placebo tablets administered orally QD on specified days

Первичные конечные точки

• Proportion of patients achieving PASI 75 response at Week 16 [Срок оценки: Baseline to Week 16]
• Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 16 [Срок оценки: Baseline to Week 16]

Вторичные конечные точки (12)

• Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation [Срок оценки: Baseline to Week 56]
• Number of participants with clinical laboratory abnormalities [Срок оценки: Baseline to Week 56]
• Incidence of clinically significant changes in electrocardiogram (ECG) [Срок оценки: Baseline to Week 56]
• Number of participants with abnormalities of physical examination [Срок оценки: Baseline to Week 56]
• Number of participants with abnormalities of vital signs [Срок оценки: Baseline to Week 56]
• PASI 75 response rates at specified time points [Срок оценки: Baseline to Week 56]
• PASI 90 response rates at specified time points [Срок оценки: Baseline to Week 56]
• PASI 100 response rates at specified time points [Срок оценки: Baseline to Week 56]
• Proportion of patients with sPGA 0/1 at specified time points [Срок оценки: Baseline to Week 56]
• Proportion of patients with sPGA 0 at specified time points [Срок оценки: Baseline to Week 56]
• Proportion of patients achieving PSSD symptom score of 0 at specified time points among patients with a baseline symptom score ≥1 [Срок оценки: Baseline to Week 56]
• Proportion of patients achieving DLQI 0/1 at specified time points among patients with a baseline DLQI score ≥2 [Срок оценки: Baseline to Week 56]

Критерии участия

Критерии включения

• Male or female subjects aged 18 years and older
• Diagnosis of plaque psoriasis for at least 6 months
• Eligible for phototherapy or systemic therapy
• Plaque covering ≥ 10% of BSA
• PASI ≥ 12, sPGA ≥3

Критерии исключения

• Diagnosis of non-plaque psoriasis or drug-induced psoriasis
• Recent history of infection, history or risk of serious infection
• Any major illness or evidence of unstable condition of major organ systems including psychiatric disease
• Any condition possibly affecting the PK process of the study drug
• Evidence of other skin conditions that would interfere with the evaluation of psoriasis
• History of hypersensitivity to the ingredients of study drugs, history of anaphylaxis
• Prior exposure to TYK2 inhibitors
• Have received the prohibited treatment during the protocol required washout period
• Any significant laboratory or procedure abnormalities that might place the subject at unacceptable risk during this study period

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Huashan Hospital affiliated to Fudan University — Шанхай

Идентификаторы

NCT: NCT06672393 · HS-10374-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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