エフィサイル™ON:以前の研究に参加した全身性膿疱性乾癬患者におけるスペソリマブの長期治療を検証する研究
基本情報
- NCT ID
- NCT03886246
- ステータス
- 実施中(募集終了)
- 試験のフェーズ
- 第2相
- 試験タイプ
- 介入
- 目標被験者数
- 131
- 治験依頼者名
- Boehringer Ingelheim
概要
This study is open to people with generalized pustular psoriasis (GPP). People can only take part if they have completed treatment in a previous study with spesolimab (1368-0013 or 1368-0027). The goal of this study is to find out how well people with GPP tolerate long-term treatment with spesolimab. The study also tests whether spesolimab helps improve GPP symptoms and how quickly the symptoms improve after a flare-up. Every participant gets spesolimab for almost 5 years (252 weeks). Depending on their symptoms and whether they had a GPP flare during the previous trial, they get spesolimab every few weeks. When participants have a GPP flare during this trial, they get spesolimab as an infusion into a vein. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. To assess the study endpoints, doctors regularly check participants' skin.
対象疾患
介入
依頼者(Sponsor)
実施施設 (4)
東京医科大学病院
Ibaraki, Inashiki-gun, Japan
埼玉医科大学病院
Saitama, Iruma-gun, Japan
東京医科大学八王子医療センター
Tokyo, Hachioji, Japan
名古屋市立大学病院
Aichi, Nagoya, Japan