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ブロダルマブの第4相臨床試験
基本情報
- NCT ID
- NCT04183881
- ステータス
- 完了
- 試験のフェーズ
- 第4相
- 試験タイプ
- 介入
- 目標被験者数
- 138
- 治験依頼者名
- Kyowa Kirin Co., Ltd.
概要
This study \[4827-005 (post market)\] is designed to evaluate the safety and efficacy of long-term exposure to brodalumab in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic arthritis) who have completed Study 4827-003 (Study 003) and in subjects with pustular psoriasis (generalized) or psoriatic erythroderma who have completed the Study 4827-004 (Study 004). 4827-005 study was conducted as phase 3 clinical trial until July 4th 2016 (approval date in Japan). After that date 4827-005 study was switched to phase 4 study.
対象疾患
Psoriasis VulgarisPsoriatic ArthritisPustular; Psoriasis, Palmaris Et PlantarisPsoriatic Erythroderma
介入
Brodalumab 210mg SC(DRUG)
依頼者(Sponsor)
協和キリン株式会社(INDUSTRY)
実施施設 (1)
The Jikei University Scoole of Medicine
Tokyo, Japan