BI 3000202の異なる用量が全身性エリテマトーデス(SLE)患者に効果があるかどうかを検証する研究
基本情報
- NCT ID
- NCT07409181
- ステータス
- 募集前
- 試験のフェーズ
- 第2相
- 試験タイプ
- 介入
- 目標被験者数
- 405
- 治験依頼者名
- Boehringer Ingelheim
概要
This study is open to adults with systemic lupus erythematosus (SLE). The purpose of this study is to find out whether a medicine called BI 3000202 helps people with SLE. The study tests different doses of BI 3000202 and aims to find the best dose for people with this condition. Participants are put into 5 groups randomly, which means by chance. 4 groups get different doses of BI 3000202, and 1 group gets a placebo. Placebo tablets look like BI 3000202 tablets but do not contain any medicine. Participants take the tablets for 1 year. All participants also continue their regular treatment for SLE. Participants are in the study for a bit longer than 1 year. During this time, they visit the study site regularly. Doctors check the participants' health and take note of any unwanted effects. They also compare the results between the groups to see if the treatment works.
対象疾患
介入
依頼者(Sponsor)
実施施設 (15)
新潟大学医歯学総合病院
Niigata, Niigata, Japan
岡山赤十字病院
Okayama, Okayama, Japan
独立行政法人国立病院機構千葉東病院
Chiba, Chiba, Japan
産業医科大学病院
Fukuoka, Kitakyushu, Japan
東京科学大学病院
Tokyo, Bunkyo-ku, Japan
東北医科薬科大学病院
Miyagi, Sendai, Japan
Saitama Medical University Hospital
Saitama, Iruma-gun, Japan
信州大学医学部附属病院
Nagano, Matsumoto, Japan
聖路加国際病院
Tokyo, Chuo-ku, Japan
宮崎大学医学部附属病院
Miyazaki, Miyazaki, Japan
Juntendo University Urayasu Hospital
Chiba, Urayasu, Japan
独立行政法人地域医療機能推進機構 中京病院
Aichi, Nagoya, Japan
慶應義塾大学病院
Tokyo, Shinjuku-ku, Japan
順天堂大学医学部附属順天堂医院
Tokyo, Bunkyo-ku, Japan
北海道大学病院
Hokkaido, Sapporo, Japan