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局所処方療法で十分にコントロールできない、または局所処方療法が推奨されない結節性痒疹患者の治療におけるデュピルマブの研究(LIBERTY-PN PRIME)

基本情報

NCT ID
NCT04183335
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
151
治験依頼者名
Sanofi

概要

Primary Objective: To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapies or when those therapies are not advisable. Secondary Objectives: To demonstrate the efficacy of dupilumab on additional itch endpoints in participants with PN, inadequately controlled on topical prescription therapies or when those therapies are not advisable. To demonstrate efficacy of dupilumab on skin lesions of PN. To demonstrate the improvement in health-related quality of life. To evaluate safety outcome measures. To evaluate immunogenicity of dupilumab.

対象疾患

Neurodermatitis

介入

Dupilumab SAR231893(DRUG)
Placebo(DRUG)
Moisturizers(DRUG)
Low to medium potent topical corticosteroids(DRUG)
Topical calcineurin inhibitors(DRUG)

依頼者(Sponsor)