Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multinational, multicenter study to evaluate the efficacy and safety of amlitelimab by subcutaneous injection in participants aged 12 years and older with moderate-to-severe atopic dermatitis on background topical corticosteroids - EFC17561 - SHORE - EFC17561

Sanofi-Aventis Recherche & Developpement0 个研究点目标入组 567 人开始时间: 2024年2月21日最近更新: 2024年8月21日

研究概览

暂无简介。

•Participants must be 12 years of age (when signing informed consent form), Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria), Documented history (within 6 months before screening) of inadequate response to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening), v-IGA-AD of 3 or 4 at baseline visit, EASI score of 16 or higher at baseline, AD involvement of 10% or more of BSA at baseline, Weekly average of daily PP-NRS of = 4 at baseline visit., Able and willing to comply with requested study visits and procedures, Body weight =25 kg

•Skin co-morbidity that would adversely affect the ability to undertake AD assessments, History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP), Known history of or suspected significant current immunosuppression, Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured >5 years prior to baseline), History of solid organ or stem cell transplant, Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline, Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit, Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB, Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit, In the Investigator’s opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening

发起方

Sanofi-Aventis Recherche & Developpement