Recruiting

Phase 3

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

Sponsor:

Sanofi

Code:

NCT07185009

Conditions

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Interventions

Duvakitug

Placebo

Study Details

Brief summary:

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance 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 286 weeks including:

40-week Pivotal Maintenance Sub-Study
240-week Open-Label Extension (OLE) Sub-Study
45-day Follow-up Visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.

The treatment duration may be up to 280 weeks including:

40 weeks in Pivotal Maintenance Sub-Study
240 weeks in OLE Sub-Study

The total number of on-site visit will be up to 32:

21 visits in the Pivotal Maintenance Sub-Study.
11 visits in the OLE Sub-Study.

Conditions

Ulcerative Colitis

Study ID

NCT07185009

Start date

Jan 16, 2026

Status verified date

Oct, 2026

Completion date

Apr 28, 2033

Anticipated

Primary completion date

Sep 21, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to <18 years of age who meet the definition of Tanner stage 5 for development)
Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of SUNSCAPE-1
OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study

Exclusion Criteria:

Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator
Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Design

Enrollment

751 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Duvakitug - dose 1

Subcutaneous (SC) injection as per protocol

experimental: Duvakitug - dose 2

SC injection as per protocol

experimental: Duvakitug - dose 3

SC injection as per protocol

placebo comparator: Placebo

SC injection as per protocol

Interventions

Duvakitug

Pharmaceutical form: Injection solution Route of administration: SC injection

Placebo

Pharmaceutical form:Injection solution-Route of administration:SC injection

Primary outcome measure

Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by modified Mayo Score (mMS). [ Time Frame: Week 40 ]

Central Contacts and Locations

Central contacts

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

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

Locations

Del Sol Research Management, LLC - Site Number: 8400012

Recruiting

Tucson, Arizona, United States, 85715

Southern California GI & Liver Centers - Site Number: 8400062

Recruiting

Coronado, California, United States, 92118

United Medical Doctors CA - Site Number: 8400044

Recruiting

Murrieta, California, United States, 92563

Om Research, LLC - Victorville - Site Number: 8400022

Recruiting

Victorville, California, United States, 92395

Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039

Recruiting

Colorado Springs, Colorado, United States, 80907

Clinical Research of Osceola - Site Number: 8400013

Recruiting

Kissimmee, Florida, United States, 34741

Bioresearch Partner-Kendale Lakes - Site Number: 8400053

Recruiting

Miami, Florida, United States, 33155

NMC Research LLC - Site Number: 8400033

Recruiting

Tampa, Florida, United States, 33607

Atlanta Gastroenterology Associates-Site Number: 8400109

Recruiting

Atlanta, Georgia, United States, 30342

Grand Teton Research Group, PLLC-Site Number: 8400127

Recruiting

Idaho Falls, Idaho, United States, 83404

GI Alliance - Gurnee-Site Number:

Recruiting

Gurnee, Illinois, United States, 60031

Gastroenterology Health Partners, PLLC - New Albany - Site Number: 8400100

Recruiting

New Albany, Indiana, United States, 47150

University of Kentucky Hospital/UK Albert B. Chandler Hospital-Site Number: 8400058

Recruiting

Lexington, Kentucky, United States, 40536-0293

GI Alliance - Baton Rouge - Site Number: 8400129

Recruiting

Baton Rouge, Louisiana, United States, 70809

Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville - Site Number: 8400128

Recruiting

Mandeville, Louisiana, United States, 70471

Delta Research Partners - Site Number: 8400087

Recruiting

Monroe, Louisiana, United States, 71291

UMass Memorial Medical Center-Site Number: 8400121

Recruiting

Worcester, Massachusetts, United States, 01655

Gastroenterology Associates of Western Michigan - Site Number: 8400060

Recruiting

Wyoming, Michigan, United States, 49519

Gateway Gastroenterology - Site Number: 8400097

Recruiting

Chesterfield, Missouri, United States, 63017

BVL Clinical Research - Site Number: 8400005

Recruiting

Liberty, Missouri, United States, 64068

Premier Health Research, LLC-Site Number: 8400114

Recruiting

Sparta, New Jersey, United States, 07871

MedTraits NY - Site Number: 8400045

Recruiting

Maspeth, New York, United States, 11378

NYU Langone Health-Site Number: 8400091

Recruiting

New York, New York, United States, 10016

Weill Cornell Medicine - NewYork-Presbyterian Hospital - Site Number: 8400040

Recruiting

New York, New York, United States, 10065

Lenox Hill Hospital-Site Number: 8400052

Recruiting

New York, New York, United States, 10075

New York Gastroenterology Associates - Site Number: 8400009

Recruiting

New York, New York, United States, 10075

Cross Creek Medical Clinic - Site Number: 8400057

Recruiting

Fayetteville, North Carolina, United States, 28304

Ohio Gastroenterology Group Inc. - Site Number: 8400006

Recruiting

Columbus, Ohio, United States, 43202

North Shore Gastroenterology Research - Site Number: 8400130

Recruiting

Westlake, Ohio, United States, 44145

The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

University Gastroenterology-Site Number: 8400103

Recruiting

Providence, Rhode Island, United States, 02904

One of a Kind Clinical Research Center TX, LLC-Site Number: 8400125

Recruiting

Kingwood, Texas, United States, 77339

GI Alliance - Lubbock - Site Number: 8400092

Recruiting

Lubbock, Texas, United States, 79410

Gastroenterology Research of San Antonio LLC - Site Number: 8400054

Recruiting

San Antonio, Texas, United States, 78229

Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Corporate Office - Site Number: 8400101

Recruiting

Southlake, Texas, United States, 76092

Tyler Research Institute, LLC - Site Number: 8400095

Recruiting

Tyler, Texas, United States, 75701

The Vancouver Clinic Inc. P.S. - Site Number: 8400090

Recruiting

Vancouver, Washington, United States, 98664

Investigational Site Number : 1240003

Recruiting

Toronto, Ontario, Canada, M6A 3B4

Investigational Site Number : 1240004

Recruiting

Edmonton, Canada, T6G 2X8

Investigational Site Number : 1240009

Recruiting

Hamilton, Canada, L8N 1Y2

Investigational Site Number : 1240013

Recruiting

London, Canada, N6K 1M6

Investigational Site Number : 1240006

Recruiting

New Westminster, Canada, BC V3L 3W4

More Information

Sponsor

Sanofi

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Sanofi on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.