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Идёт набор NCT06842199

Efficacy, Safety, Pharmacokinetics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis

Фаза III С лечением Plaque Psoriasis Patients

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ICP-488 Tablets, ICP-488 Placebo.
Кому может быть актуально
Состояния в реестре: Plaque Psoriasis Patients. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Oral ICP-488 in Patients With Moderate to Severe Plaque Psoriasis

Обзор

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy, safety, PK characteristics of ICP-488 in Chinese adults with moderate to severe plaque psoriasis.

Вмешательства

  • Препарат ICP-488 Tablets
    Eligible patients will receive ICP-488 orally as per the protocol
  • Препарат ICP-488 Placebo
    Eligible patients will receive ICP-488 Placebo orally as per the protocol

Первичные конечные точки

  • The proportion of subjects who achieve a score of clear (0) or almost clear (1) with an improvement of at least 2 points from baseline on the static Physician's Global Assessment (sPGA) at week 16 [Срок оценки: week 16]
  • Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 16 [Срок оценки: Week 16]
Вторичные конечные точки (5)
  • Adverse events [Срок оценки: Week 52]
  • Percentage of subjects with PASI 50/75/90/100 in each planned visit [Срок оценки: Week 52]
  • Percentage of subjects with sPGA score of 0 (clear) or 1 (almost clear) and an improvement of at least 2 points from baseline in planned visits. [Срок оценки: Week 52]
  • The proportion of subjects with sPGA score of 0 in each planned visit. [Срок оценки: Week 52]
  • PK parameter: ICP-488 and its metabolite. [Срок оценки: Week 52]

Критерии участия

Критерии включения

Eligible subjects must meet all of the following criteria:

  • Subjects voluntarily participate in this study and have signed informed consent.
  • Male or female subjects between the ages of 18 and 75 (including the threshold) at the time of signing the ICF.
  • History of plaque psoriasis ≥6 months at baseline.
  • Subjects need to receive systemic therapy and/or phototherapy.
  • The following three criteria were met: a) psoriasis Area and Severity index (PASI) score ≥12; b) Psoriasis affected body surface area (BSA) ≥10%; c) Static physician overall assessment (sPGA) ≥3 scores

Критерии исключения

  • The diagnosis was non-plaque psoriasis.
  • Subjects with concurrent skin diseases that the investigator believes would interfere with the study assessments.
  • Presence of infection or immune-related disease.
  • Subjects with a history of TB or at risk for TB.
  • Received related treatment within the time window specified in the protocol.
  • An interval of less than 5 half-lives or 28 days (if any available half-life data) from the last dose of a strong CYP1A2/CYP3A4 inhibitor or inducer, or a plan to use concurrently medications with strong CYP1A2/CYP3A4 inhibitory or inductive effect during study participation.
  • The investigator has determined that there are clinically significant test results and that participation in this trial would pose an unacceptable risk to patients; Or the laboratory values of the subjects in the screening period meet the criteria specified in the protocol.
  • Pregnant or lactating women, or women who plan to become pregnant during study participation.
  • A history of severe drug allergies.
  • Any other conditions in which the investigator considers it unsuitable for the subject to participate in this 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
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 46 центров
  • The First Affiliated Hospital of Anhui Medical University — Хэфэй
  • The Second Affiliated Hospital of Wannan Medical College — Wuhu
  • Beijing Chao-Yang Hospital，Capital Medical University — Пекин
  • Beijing Friendship Hospital, Capital Medical University — Пекин
  • Peking University Third Hospital — Пекин
  • Beijing Tongren Hospital,CMU — Пекин
  • The First Affiliated Hospital of Chongqing Medical University — Чунцин
  • Chongqing Traditional Chinese Medicine Hospital — Чунцин
  • … и ещё 38 центров

Идентификаторы

NCT: NCT06842199 · ICP-CL-01005

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗