NCT05668013

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

A Phase 2b, Randomized, Double-Blind Long-Term Extension Study to Evaluate Pharmacokinetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Completed the Treatment Phase of the Dose-Ranging Study (RELIEVE UCCD LTE)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn Disease
• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	TEV-48574 Dose Regimen A	Subcutaneous (sc) administration using a commercial sc infusion system
DRUG	TEV-48574 Dose Regiment B	Subcutaneous (sc) administration using a commercial sc infusion system

Timeline

• Start date: 2023-01-11
• Primary completion: 2026-01-05
• Completion: 2031-03-08
• First posted: 2022-12-29
• Last updated: 2026-03-27

Locations

93 sites across 16 countries: United States, Austria, Bulgaria, Czechia, Georgia, Germany, Hungary, Israel, Italy, Japan, Norway, Poland, Slovakia, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study