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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)

実施施設 (1)

The Jikei University Scoole of Medicine

Tokyo, Japan