A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis

Официальное название

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis

Обзор

A Study to evaluate efficacy and safety in subjects with moderate to severe Plaque Psoriasis treated with a TYK2 Inhibitor for 12 weeks

Вмешательства

• Препарат Tyk2 inhibitor
  Specific dose of Tyk2 inhibitor on specific days
• Препарат Placebo
  Specified dose of Placebo on specified days.

Первичные конечные точки

• The Percentage of Participants Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Week 12 [Срок оценки: Baseline to Week 12]

Вторичные конечные точки (8)

• Percentage of Participants With PASI-90, PASI-100 on Week 12 [Срок оценки: Baseline to Week 12]
• Percentage of Participants on Week 12 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate) [Срок оценки: Baseline to Week 12]
• Change From Baseline in DLQI Scores to Week 12 [Срок оценки: Baseline to Week 12]
• Change From Baseline in BSA to Week 12 [Срок оценки: Baseline to Week 12]
• Number of Participants With Adverse Events [Срок оценки: From enrollment to Day 112]
• Mean steady-state plasma concentration of the drug (Cav,ss) [Срок оценки: Day 1, Day 8, Day 15, Day 29, Day 57, Day 84]
• Steady-state trough plasma concentration of the drug (Ctrough, ss) [Срок оценки: Day 1, Day 8, Day 15, Day 29, Day 57, Day 84]
• The area under the steady-state blood drug concentration-time curve (AUCss) [Срок оценки: Day 1, Day 8, Day 15, Day 29, Day 57, Day 84]

Критерии участия

Критерии включения

• Male and female, ages 18 to 70 years
• Body weight >40 kg, body mass index (BMI) of 18 to 40 kg/m2
• Clinical diagnosis of plaque psoriasis for ≥6 months before the Baseline visit
• Women of childbearing potential (WOCBP) and males who are sexucally active must agree to follow instructions for method(s) of contraception.

Критерии исключения

• Diagnosed with non-plaque psoriasis
• Previously received tyrosine kinase 2 (TYK2) inhibitors
• Previously received other psoriasis treatments such as biological agents, immunoregulators, or hormonal drugs within a specific period before administration, and the investigator deems it may affect the immunity of the subjects
• Has participated in any clinical trials within 30 days or 5 half-lives of the drug before the first administration, or currently undergoing visits for other clinical trials;
• Has history of chronic disease that may affect the study, or acute or chronic severe infectious diseases, such as a history of active or inadequately treated latent tuberculosis infection, severe bone or joint infections within 6 months before screening, and other acute infectious diseases.
• Has known or suspected skin or systemic autoimmune diseases other than psoriasis and psoriatic arthritis;
• Other conditions that the investigator deems unsuitable for participation in this study.

Other protocol defined inclusion/exclusion criteria could apply

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

• Shanghai Skin Disease Hospital — Шанхай

Идентификаторы

NCT: NCT07234591 · CN101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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