A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease

第2相 完了 NCT05499130

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.

Number of Participants With Moderate to Severe UC Who Showed Clinical Remission as Defined by the MMS

Week 14 · Participants

Number of Participants With Moderate to Severe CD Who Showed an Endoscopic Response as Defined by the SES-CD

Baseline to Week 14 · Participants

BENITIONS で見る ClinicalTrials.gov の原文を見る

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