A randomized double blind placebo controlled study evaluating the effect of dupilumab on sleep in adult patients with moderate to severe atopic dermatitis - DUPISTAD

Sanofi Aventis Groupe0 个研究点目标入组 268 人开始时间: 2020年1月22日最近更新: 2021年10月18日

研究概览

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•Participants, male or female 18 years or older,
•- with diagnosed chronic atopic dermatitis (AD), demonstrated 1) inadequate response to topical medications, 2) expected severity of AD and 3) sleep disturbance
•- having applied skin emolients (moisturizers) at least 7 days before randomization
•- having applied medium potency topical corticosteroids (TCS) on all active AD lesions at least 7 days before randomization
•- willing and able to comply with all clinic visits and study-related procedures
•- providing signed informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 253
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•Participants excluded from the study:
•- with known hypersensitivity to Dupixent, clinical depression, drug abuse history, sleep problems not related to AD, irregular sleep pattern, active/acute infections, severe medical conditions, laboratory abnormalities, any condition that may present unreasonable risk to patients or interfere with study assessment, or any severe concomitant illness(es) that would adversely affect the patient's participation in the study, and contraindications of topical corticosteroids
•- at baseline, presence of any conditions listed as criteria for study drug discontinuation
•The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

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