A Phase II Efficacy and Safety Study of HSK44459 in Subjects With Moderate to Severe Plaque Psoriasis

Официальное название

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK44459 in Subjects With Moderate to Severe Plaque Psoriasis

Обзор

The purpose of this study is to assess the efficacy and safety of HSK44459 administered orally for moderate to severe plaque psoriasis in adults.

Подробное описание

Patients with moderate to severe plaque psoriasis will be randomized into 3 cohorts (dose level 1, dose level 2 and placebo). Approximately 150 subjects will be enrolled. This study includes an 16-week treatment Period, then a 4-week safety visit period.

Вмешательства

• Препарат HSK44459 dose level 1
  HSK44459 dose level 1 oral administration
• Препарат HSK44459 dose level 2
  HSK44459 dose level 2 orally administration
• Препарат placebo
  placebo oral adminisitration

Первичные конечные точки

• Proportion of subjects who have ≥75% reduction in PASI (PASI-75). [Срок оценки: 16 weeks]

Вторичные конечные точки (4)

• Proportion of subjects achieving an IGA score of clear 0 or 1 with ≥2 point reduction from baseline. [Срок оценки: 2, 4, 8, 12 and 16 weeks]
• Proportion of subjects who have ≥75% reduction in PASI (PASI-75). [Срок оценки: 2, 4, 8 and 12 weeks]
• Proportion of subjects who have ≥50% reduction in PASI (PASI-50). [Срок оценки: 2, 4, 8, 12 and 16 weeks]
• Proportion of subjects who have ≥90% reduction in PASI (PASI-90). [Срок оценки: 2, 4, 8, 12 and 16 weeks]

Критерии участия

Критерии включения

• Fully understand and voluntarily participate this trial, and sign the informed consent form;
• Age≥18 years, regardless of gender;
• Plaque psoriasis;
• A candidate for systemic therapy;
• Agree to use a highly effective method(s) of from the signing of the informed consent form to 3 months post-treatment.

Критерии исключения

• Can not discontinue the prohibited medications specified in the protocol before the first dose and throughout the entire study period;
• Laboratory abnormalities with clinical significance;
• Forms of psoriasis other than chronic plaque-type;
• Presence of other dermatological or autoimmune diseases;
• Presence of active infection requiring systemic therapy;
• Has undergone or plans to undergo major surgery;
• History of cardiovascular or cerebrovascular diseases;
• History of suicide attempts or major psychiatric disorders;
• History of malignant tumors;
• History of gastrointestinal surgery or diseases that may have impact on the study;
• History of drug abuse, illicit drug use, or alcohol abuse;
• History of severe drug allergies;
• Pregnant or lactating women;
• Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.

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

• Hangzhou First People's Hospital — Ханчжоу

Идентификаторы

NCT: NCT07150988 · HSK44459-206

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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