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NCT07185009PHASE3Recruiting

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

Sanofi

Start Date

1/16/2026

Completion Date

4/28/2033

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.

Eligibility Criteria

Age Range: 16 years to 80 years

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.

Interventions

DRUG

Duvakitug

DRUG

Placebo

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Conditions

Ulcerative Colitis

Locations

Del Sol Research Management, LLC - Site Number: 8400012

Tucson, Arizona 85715

United States

Southern California GI & Liver Centers - Site Number: 8400062

Coronado, California 92118

United States

United Medical Doctors CA - Site Number: 8400044

Murrieta, California 92563

United States

Om Research, LLC - Victorville - Site Number: 8400022

Victorville, California 92395

United States

Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039

Colorado Springs, Colorado 80907

United States

Royal Palm Clinical Research - Site Number: 8400065

Fort Myers, Florida 33901

United States

Clinical Research of Osceola - Site Number: 8400013

Kissimmee, Florida 34741

United States

Bioresearch Partner-Kendale Lakes - Site Number: 8400053

Miami, Florida 33155

United States

NMC Research LLC - Site Number: 8400033

Tampa, Florida 33607

United States

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

New Albany, Indiana 47150

United States

GI Alliance - Baton Rouge - Site Number: 8400129

Baton Rouge, Louisiana 70809

United States

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

Mandeville, Louisiana 70471

United States

Delta Research Partners - Site Number: 8400087

Monroe, Louisiana 71291

United States

Gastroenterology Associates of Western Michigan - Site Number: 8400060

Wyoming, Michigan 49519

United States

Gateway Gastroenterology - Site Number: 8400097

Chesterfield, Missouri 63017

United States

BVL Clinical Research - Site Number: 8400005

Liberty, Missouri 64068

United States

MedTraits NY - Site Number: 8400045

Maspeth, New York 11378

United States

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

New York, New York 10065

United States

New York Gastroenterology Associates - Site Number: 8400009

New York, New York 10075

United States

Cross Creek Medical Clinic - Site Number: 8400057

Fayetteville, North Carolina 28304

United States

Ohio Gastroenterology Group Inc. - Site Number: 8400006

Columbus, Ohio 43202

United States

OSU Wexner Medical Center - Site Number: 8400077

Columbus, Ohio 43210

United States

North Shore Gastroenterology Research - Site Number: 8400130

Westlake, Ohio 44145

United States

GI Alliance - Lubbock - Site Number: 8400092

Lubbock, Texas 79410

United States

Gastroenterology Research of San Antonio LLC - Site Number: 8400054

San Antonio, Texas 78229

United States

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

Southlake, Texas 76092

United States

Tyler Research Institute, LLC - Site Number: 8400095

Tyler, Texas 75701

United States

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

Vancouver, Washington 98664

United States

Investigational Site Number : 1240003

Toronto, Ontario M6A 3B4

Canada

Charlton Digestive Disease Centre - Site Number : 1240009

Hamilton, L8N 1Y2

Canada

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC - Site Number : 2680002

Tbilisi, 0180

Georgia

Tokai University Hachioji Hospital - Site Number : 3920031

Hachiōji, 192-0032

Japan

Investigational Site Number : 3920049

Kagoshima, 892-0843

Japan

Investigational Site Number : 3920030

Kamakura, 247-0056

Japan

Investigational Site Number : 3920019

Kobe, 650-0015

Japan

Investigational Site Number : 3920029

Sapporo, 004-0041

Japan

Investigational Site Number : 3920009

Tsu, 514-8507

Japan

Investigational Site Number : 4400002

Panevezys, 35144

Lithuania

SONOMED - Site Number : 6160020

Szczecin, 71-685

Poland

Investigational Site Number : 6880001

Belgrade, 11,000

Serbia

Investigational Site Number : 6880002

Belgrade, 11000

Serbia

Investigational Site Number : 8040001

Kyiv, 2002

Ukraine

Investigational Site Number : 8040002

Kyiv, 3037

Ukraine

Investigational Site Number : 8040005

Lviv, 79019

Ukraine

Investigational Site Number : 8040006

Uzhhorod, 88018

Ukraine

Investigational Site Number : 8040008

Vinnytsia, 21029

Ukraine