BI655130（スペソリマブ）による中等症から重症の潰瘍性大腸炎患者への導入療法

基本情報

NCT ID

NCT03482635

ステータス

完了

試験のフェーズ

第2/第3相

試験タイプ

介入

目標被験者数

98

治験依頼者名

Boehringer Ingelheim

概要

This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are * to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II) * to confirm efficacy and safety of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III) * To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.

対象疾患

介入

依頼者（Sponsor）

実施施設 (10)