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

NCT05499130 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2026-03-27

Study results available
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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

DRUG

TEV-48574

Subcutaneous infusion

DRUG

Placebo

Matching Placebo

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2024-11-12
Completion
2024-11-12
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Georgia
  • Germany
  • Hungary
  • Israel
  • Italy
  • Japan
  • Norway
  • Poland
  • Slovakia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05499130 on ClinicalTrials.gov