Clinical Trial

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

Active, Not Recruiting Phase 2
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Summary
The primary objective of the study is to evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 4 weeks (Q4W) in adult participants with inflammatory bowel disease (IBD). Secondary objectives of the study are to: * evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD * evaluate the safety and tolerability of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD * evaluate the immunogenicity of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD The total duration for a participant in the double-blind period only is 66 weeks; and for a participant in the open-label extension (OLE) period, up to an additional 268 weeks.
Protocol Amendment History 42 amendments
This ClinicalTrials.gov record has been amended 42 times since 2022-12-19; most recent amendment 2026-07-23.
Status change: Recruiting → Active, Not Recruiting 2024-11-26
Status change: Not Yet Recruiting → Recruiting 2023-02-02
Trial Details
NCT Number NCT05668013
Lead Sponsor Teva Branded Pharmaceutical Products R&D LLC
Collaborators: Sanofi
Conditions Crohn Disease, Colitis, Ulcerative
Enrollment 247 participants
Start Date 2023-01-11
Primary Completion 2026-01-05 (estimated)
Study Completion 2031-03-08 (estimated)
Updated on ClinicalTrials.gov 2026-08-07