Идёт набор NCT07037901

A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

Фаза II С лечением Atopic Dermatitis Atopic Dermatitis Eczema Eczema

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: IMG-007, Placebo.
Кому может быть актуально: Состояния в реестре: Atopic Dermatitis, Atopic Dermatitis Eczema, Eczema. Базовые параметры: 18 лет — 74 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: США, Канада
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 Phase 2b, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

Обзор

The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.

Подробное описание

A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety profile of various dose regimens of IMG-007 in adult participants with moderate-to-severe active atopic dermatitis (AD) up to 48 weeks.

Вмешательства

Препарат IMG-007
Participants will receive IMG-007 subcutaneously.
Препарат Placebo
Participants will receive a placebo subcutaneously.

Первичные конечные точки

Mean percent change from baseline in EASI at Week 24 [Срок оценки: Baseline, Week 24]

Вторичные конечные точки (4)

Proportion of participants achieving a vIGA-AD score of 0 (clear) or 1 (almost clear) and a ≥ 2-point reduction from baseline at Week 24 [Срок оценки: Baseline, Week 24]
Proportion of participants achieving a ≥ 75% reduction in EASI (EASI-75) at Week 24 [Срок оценки: Baseline, Week 24]
Proportion of participants achieving a ≥ 90% reduction in EASI (EASI-90) at Week 24 [Срок оценки: Baseline, Week 24]
Incidence and severity of TEAE including treatment-emergent SAEs [Срок оценки: Baseline, End of Study]

Критерии участия

Критерии включения

Moderate-to-severe AD
Documented history of inadequate response or lack of tolerability to a stable regimen of one or more topical treatment before the Screening visit, or for whom topical treatments are otherwise inadvisable
Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception
Male participants must agree to use a highly effective method of contraception
EASI score ≥16
vIGA-AD score ≥3
≥10% body surface area (BSA) of AD involvement
Mean peak pruritus numerical rating scale ≥ 4 during 7-days before randomization

Критерии исключения

Positive hepatitis B, hepatitis C, or human immunodeficiency virus infection
Evidence of active or latent tuberculosis (TB)
History of untreated or inadequately treated TB infection
Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals
Active unstable pruritic skin conditions in addition to AD that would interfere with the assessment of AD based on the investigator's clinical judgement
Other conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study
Having received any of the specified therapies within the specified timeframe(s) prior to the Baseline visit

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет