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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)