MedTrace Logo

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT07184931 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 980

Last updated 2026-04-27

No results posted yet for this study

Summary

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include:

The study duration may be up to 35 weeks with:

* Up to 5-week 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).
* 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study.

The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.

Conditions

Interventions

DRUG

Duvakitug

Pharmaceutical form:Injection solution Route of administration:SC injection

DRUG

Placebo

Pharmaceutical form:Injection solution 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
2025-10-01
Primary Completion
2029-05-14
Completion
2029-05-14
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Bulgaria
  • Canada
  • China
  • Czechia
  • Georgia
  • Germany
  • Hungary
  • Japan
  • Moldova
  • Poland
  • Puerto Rico
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • 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 NCT07184931 on ClinicalTrials.gov