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日本人アトピー性皮膚炎患者におけるデュピルマブ

基本情報

NCT ID
NCT04678882
ステータス
完了
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
62
治験依頼者名
Sanofi

概要

Primary Objective: To evaluate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) Secondary Objective: To evaluate the efficacy of dupilumab administered concomitantly with TCS. To assess the safety of dupilumab over 16 weeks of treatment when administered concomitantly with TCS in participants. To assess immunogenicity as determined by the incidence, titer, and clinical impact of treatment-emergent anti-drug antibodies (ADA) to dupilumab over time in pediatric patients with atopic dermatitis (AD) (aged ≥6 months to \<18 years old) To assess the concentration of dupilumab in serum following administration concomitantly with TCS.

対象疾患

Atopic Dermatitis

介入

Placebo(DRUG)
Dupilumab SAR231893(DRUG)

依頼者(Sponsor)