中等度から重度の潰瘍性大腸炎またはクローン病におけるTEV-48574の効果を検証する研究

基本情報

NCT ID

NCT05499130

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

290

治験依頼者名

Teva Branded Pharmaceutical Products R&D, Inc.

概要

The primary objective is to characterize the efficacy TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14. Secondary objectives: * To evaluate the efficacy of 2 different doses of TEV-48574 as assessed by multiple standard measures * To evaluate the safety and tolerability of 2 different doses of TEV-48574 * To evaluate the immunogenicity of 2 different dioses of TEV-48574 The study will consist of a screening period of up to 6 weeks (42 days), a 14-week treatment period, and a 4-week follow-up period.

対象疾患

介入

依頼者（Sponsor）

実施施設 (9)