Loading clinical trials...

RECRUITINGPHASE3

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

A Multicenter, Multinational, 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.

NCT07184996•Sanofi

View on ClinicalTrials.gov

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.

Eligibility

Age

16 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to \<18 years of age who meet the definition of Tanner Stage 5 for development
•Confirmed diagnosis of moderately to severely active UC for at least 3 months prior to Baseline
•Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies

Exclusion Criteria

•Participants with Crohn's Disease (CD), indeterminate colitis
•Current diagnosis of Ulcerative Proctitis
•Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of \>3 bowel resections
•Prior or current high-grade gastrointestinal (GI) dysplasia
•Participants on treatment with but not on stable doses of conventional therapies prior to baseline
•Participants with prohibited medications or therapies prior to baseline
•Participants with previous exposure to anti-TL1A investigational therapy The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Locations (88)

Onyx Clinical Research - Site Number: 8400021

Peoria, Arizona, United States

One of a Kind Clinical Research Center LLC - Site Number: 8400061

Scottsdale, Arizona, United States

Del Sol Research Management, LLC - Site Number: 8400012

Tucson, Arizona, United States

Preferred Research Partners - Site Number: 8400018

Little Rock, Arkansas, United States

FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027

Arcadia, California, United States

Alliance Research Institute - Site Number: 8400008

Canoga Park, California, United States

Southern California GI & Liver Centers - Site Number: 8400062

Coronado, California, United States

GMC Clinical Research, LLC - Site Number: 8400113

Folsom, California, United States

TLC Clinical Research Inc. - Site Number: 8400030

Los Angeles, California, United States

United Medical Doctors CA - Site Number: 8400044

Murrieta, California, United States

Key Dates

Start Date

October 8, 2025

Primary Completion Date

May 9, 2028

Completion Date

May 9, 2028

Last Updated

February 27, 2026

Enrollment

980

ESTIMATED participants

Conditions

Ulcerative Colitis

Interventions

Duvakitug

DRUG

Placebo

DRUG

Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610 contact-us@sanofi.com

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

NCT07271069

Ulcerative Colitis (UC)

View study

RECRUITINGPHASE2

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

NCT06975722

Ulcerative Colitis

View study

RECRUITINGPHASE3

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

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

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

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

Immunological Characteristics of Preclinical IBD