NCT05499130

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

A 14 Week Phase 2b, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Efficacy, Safety and Tolerability of TEV-48574 in Adult Patients With Ulcerative Colitis or Crohn's Disease (RELIEVE UCCD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Crohn Disease
• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	TEV-48574	Subcutaneous infusion
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2022-09-30
• Primary completion: 2024-11-12
• Completion: 2024-11-12
• First posted: 2022-08-12
• Last updated: 2026-03-27
• Results posted: 2025-12-05

Locations

164 sites across 19 countries: United States, Austria, Belgium, Bulgaria, Canada, Czechia, France, Georgia, Germany, Hungary, Israel, Italy, Japan, Norway, Poland, Slovakia, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study