jRCT2031240665招募中不适用
A Phase 2b, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 3 subcutaneous dose regimens of lunsekimig (SAR443765) in adult participants with moderate-to-severe atopic dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sanofi K.K.
- 入组人数
- 144
- 主要终点
- Percent change in EASI score from baseline to Week 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 80age old under（—）
- 性别
- All
入选标准
- •Participants must be 18 to 80 years of age, inclusive, at the time of signing the informed consent.
- •Diagnosis of Atopic Dermatitis (AD) as defined by the American Academy of Dermatology (AAD) clinical guidelines (2023) for 1 year or longer at baseline (Day 1).
- •Documented history within 6 months prior to Screening Visit, of either inadequate response or inadvisability of topical treatments.
- •Eczema Area and Severity Index (EASI) score of 16 or higher (range, 0 to 72) at baseline (Day 1).
- •Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 3 or 4 at baseline (Day 1) (on the 0 to 4 vIGA-AD scale, a vIGA-AD score of 3 and 4 represents moderate and severe, respectively).
- •AD involvement of 10% or more of Body Surface Area (BSA) at baseline (Day 1).
- •Weekly average of daily Peak Pruritis-Numerical Rating Scale (PP-NRS) score of >=4 at baseline (Day 1).
- •Must have applied a stable dose of topical bland emollient (simple moisturizer, no additives [eg, urea]) at least once daily for a minimum of 5 out of 7 consecutive days before baseline (Day 1).
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Skin comorbidity that would adversely affect the ability to undertake AD assessments (eg, psoriasis, tinea corporis, and lupus erythematosus) according to the Investigator's judgment.
- •Known history of, or suspected, significant current immunosuppression.
- •NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Percent change in EASI score from baseline to Week 24
时间窗: From Baseline throughout the study, up to Week 24
EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
次要结局
未报告次要终点
研究者
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