非分節型白斑を有する成人患者を対象とした、ウパダシチニブ経口錠剤による有害事象および疾患活動性の変化を評価する研究
基本情報
- NCT ID
- NCT04927975
- ステータス
- 完了
- 試験のフェーズ
- 第2相
- 試験タイプ
- 介入
- 目標被験者数
- 185
- 治験依頼者名
- AbbVie
概要
Vitiligo is a common chronic autoimmune disease that causes the body's immune system to attack its own pigment producing skin cells. This study is to evaluate how safe and effective upadacitinib is in participants with non-segmental vitiligo. Adverse effects and change in disease activity will be assessed. Upadacitinib is being evaluated for the treatment of non-segmental vitiligo. The study will enroll approximately 160 participants aged 18-65 with non-segmental vitiligo in 5 treatment arms across 35 sites worldwide. Participants will either receive study drug vs placebo oral tablets once daily (QD) for 24 weeks (Period A). In Period B (up to 52 weeks), participants who received placebo during the first 24 weeks will switch to study drug. Participants who received study drug during the first 24 weeks, will continue to receive study drug. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
対象疾患
介入
依頼者(Sponsor)
実施施設 (5)
地方独立行政法人山梨県立病院機構 山梨県立中央病院
Kofu, Yamanashi, Japan
東京医科大学病院
Shinjuku-ku, Tokyo, Japan
日本医科大学付属病院
Bunkyo-ku, Tokyo, Japan
国立大学法人山形大学医学部附属病院
Yamagata, Yamagata, Japan
名古屋市立大学病院
Nagoya, Aichi-ken, Japan