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An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

NCT07184996 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 980

Last updated 2026-04-24

No results posted yet for this study

Summary

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include:

The study duration may be up to 35 weeks with:

* Screening period
* 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction)
* 12-week Sub-Study 3 (Extended Induction for non-responders)
* 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359)

The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.

Conditions

Interventions

DRUG

Duvakitug

Pharmaceutical form:Solution for Injection-Route of administration:SC injection

DRUG

Placebo

Pharmaceutical form:Solution for injection-Route of administration:SC injection

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D LLC

    collaborator INDUSTRY

  • Sanofi

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-08
Primary Completion
2028-05-09
Completion
2028-05-09
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • China
  • Czechia
  • France
  • Georgia
  • Germany
  • Hungary
  • Japan
  • Lithuania
  • Moldova
  • Poland
  • Puerto Rico
  • Serbia
  • Slovakia
  • South Africa
  • Switzerland
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT07184996 on ClinicalTrials.gov