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Идёт набор NCT07330934

A Study to Evaluate Efficacy and Safety of IBI356 in Participants With Moderate to Severe Atopic Dermatitis

Фаза II С лечением Atopic Dermatitis

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: Dupilumab, Placebo, IBI356.
Кому может быть актуально
Состояния в реестре: Atopic Dermatitis. Базовые параметры: от 18 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 Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of IBI356 in Adult Participants With Moderate to Severe Atopic Dermatitis

Обзор

This is a multi-center, randomized, double-blind, parallel, placebo-controlled phase 2 clinical study. A total of 403 adult participants with moderate to severe AD are planned to be enrolled to evaluate efficacy, safety, PK characteristics, immunogenicity, and changes in PD characteristics of IBI356.

Вмешательства

  • Препарат Dupilumab
    Dupilumab by subcutaneous injection
  • Препарат Placebo
    Placebo by subcutaneous injection
  • Препарат IBI356
    IBI356 by subcutaneous injection

Первичные конечные точки

  • Percent change from baseline in Eczema Area and Severity Index (EASI) score [Срок оценки: week 24]
Вторичные конечные точки (10)
  • Proportion of participants achieving Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) with a ≥2-point reduction [Срок оценки: week 16, 24]
  • Proportion of participants with EASI-75/90/100 [Срок оценки: week16, 24]
  • Proportion of participants with a ≥4-point reduction from baseline in the weekly average of the Peak Pruritus-Numerical Rating Scale (PP-NRS) [Срок оценки: week 16, 24]
  • Change in EASI from baseline [Срок оценки: Baseline to Week 48]
  • Change in DLQI from baseline [Срок оценки: Baseline to Week 48]
  • Change in POEM from baseline [Срок оценки: Baseline to Week 48]
  • Incidences of adverse events (AEs), treatment emergent adverse events (TEAEs), and serious adverse events (SAEs) [Срок оценки: Baseline to Week 48]
  • Serum IBI356 concentrations at prespecified timepoints [Срок оценки: Baseline to Week 24]
  • Percentage of Participants with Treatment-emergent ADA of IBI356 [Срок оценки: Baseline to Week 24]
  • Serum IL-13 (PD marker) be assessed as dose-dependent drug responses [Срок оценки: Baseline to Week 48]

Критерии участия

Критерии включения

  • Able to understand and sign the informed consent form (ICF);
  • Aged ≥ 18 years, male or female;
  • Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria);
  • EASI score of 16 or higher at baseline, vIGA-AD of 3 or 4 at baseline, AD involvement of 10% or more of BSA at baseline, weekly average of daily PP-NRS of ≥ 4 at baseline;
  • Participants with documented inadequate response to topical medications or for whom topical treatments are otherwise medically inadvisable.

Критерии исключения

  • Presence of diseases that may affect the safety or efficacy, including but not limited to psychistric disorders, central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, and hematological or metabolic system diseases.
  • Known history of active tuberculosis or clinically suspected tuberculosis; or chest imaging suggesting evidence of suspected tuberculosis; or any other clinical evidence of latent tuberculosis.
  • Has known or suspected helminth or other parasitic infection.
  • History of malignancy, except excised or curatively treated localized basal cell carcinoma (BCC) or cutaneous squamous cell carcinoma (cSCC).
  • History of severe drug allergy or anaphylaxis.
  • Fainting, hemophobia, or inability to tolerate venipuncture.
  • Women who are pregnant or breastfeeding, or female participants who have a positive pregnancy test at screening or randomization.
  • Have received an organ or hematopoietic stem cell transplant.
  • Positive HBsAg; or positive HBcAb with positive HBV-DNA; or positive hepatitis C antibody with positive HCV-RNA; or positive treponema pallidum antibody; or positive HIV serology at screening.
  • Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical 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
  • Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT07330934 · CIBI356A201

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗