Overview

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

Status:
Not yet recruiting
Trial end date:
2025-06-22
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to evaluate the efficacy and dose response of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 2 weeks (Q2W) in adult participants with inflammatory bowel disease (IBD) Secondary objectives of the study are to evaluate the efficacy and dose response of 2 different maintenance dose regimens of TEV-48574 sc administered Q2W in adult participants with IBD to evaluate the safety and tolerability of 2 different dose regimens of TEV-48574 sc administered Q2W in adult participants with IBD, and to evaluate the immunogenicity of 2 different dose regimens of TEV-48574 sc administered Q2W in adult participants with IBD The total duration of participant participation in the study is planned to be 26 weeks for each individual participant. The study duration is approximately 30 months.
Phase:
Phase 2
Details
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.