Evaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis

Официальное название

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis

Обзор

This study is a randomized, double-blind, placebo-controlled multicenter clinical trial targeting subjects with moderate to severe plaque psoriasis.

Подробное описание

This study is a randomized, double-blind, placebo-controlled multicenter clinical trial targeting subjects with moderate to severe plaque psoriasis, with a total of 390 subjects planned to be enrolled.

Вмешательства

• Препарат D-2570
  Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-2570 group1, group 2 or placebo group.
• Препарат Placebo
  Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-2570 group1, group 2 or placebo group.

Первичные конечные точки

• The percentage of subjects with at least 90% improvement in PASI [Срок оценки: Day 1-Day 112]

Вторичные конечные точки (12)

• Percentage of subjects with a PGA [Срок оценки: Day 1-Day 112]
• The percentage of subjects with at least 75% improvement in PASI [Срок оценки: Day1-Day365]
• The percentage of subjects with at least 90% improvement in PASI [Срок оценки: Day1-Day365]
• The percentage of subjects with at least 100% improvement in PASI [Срок оценки: Day1-Day365]
• The percentage of subjects with improvement in PASI [Срок оценки: Day1-Day365]
• Percentage of subjects with a PGA [Срок оценки: Day1-Day365]
• The percentage of subjects with at least 90% improvement in PASI [Срок оценки: Day1-Day365]
• Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline [Срок оценки: Day1-Day365]
• Percentage of subjects with baseline ss-PGA score ≥3 [Срок оценки: Day 1-Day 112]
• Percentage of subjects with baseline PGA-F score ≥3 [Срок оценки: Day 1-Day 112]
• Percentage of subjects with baseline pp-PGA score ≥3 [Срок оценки: Day 1-Day 112]
• Percentage of subjects with baseline DLQI score ≥2 [Срок оценки: Day 1-Day 112]

Критерии участия

Критерии включения

• Subject voluntarily takes part in the study after being fully informed,signs a written ICF, and agrees to follow procedures specified in the study protocol;
• Plaque psoriasis assessed by the investigator as suitable for systemic treatment and stable (defined as stable as no significant outbreak of morphological change or disease activity assessed by the investigator) for at least 6 months prior to signing informed consent;
• During the screening period and before taking the investigational drug for the first time, psoriatic surface area (BSA) ≥10%, PGA score ≥ 3, PASI score ≥ 12;
• Hematology, Blood chemistry and Urinalysis examination were basically normal.

Критерии исключения

• Erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, reverse psoriasis, drug-induced psoriasis;
• Have other skin lesions that affect the evaluation of treatment outcomes, such as eczema;
• History of herpes zoster/herpes simplex, or presence of herpes zoster/herpes simplex infection during the screening period;
• Have a history of tuberculosis, or active tuberculosis, or latent tuberculosis, or suspected clinical manifestations of tuberculosis infection;
• Other conditions that the investigator considers inappropriate for participation in the study.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT07130604 · D2570-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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