RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Sanofi • ClinicalTrials.gov ID: NCT07185009

Registry updated: 2026-10-16

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Description

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.

Interventions

Duvakitug (Drug)
Pharmaceutical form: Injection solution Route of administration: SC injection
Placebo (Drug)
Pharmaceutical form:Injection solution-Route of administration:SC injection

Eligibility criteria

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.

Conditions

Ulcerative Colitis

Locations

Del Sol Research Management, LLC - Site Number: 8400012 — Tucson, Arizona, United States
Southern California GI & Liver Centers - Site Number: 8400062 — Coronado, California, United States
United Medical Doctors CA - Site Number: 8400044 — Murrieta, California, United States
Om Research, LLC - Victorville - Site Number: 8400022 — Victorville, California, United States
Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039 — Colorado Springs, Colorado, United States
Clinical Research of Osceola - Site Number: 8400013 — Kissimmee, Florida, United States
Bioresearch Partner-Kendale Lakes - Site Number: 8400053 — Miami, Florida, United States
NMC Research LLC - Site Number: 8400033 — Tampa, Florida, United States
Atlanta Gastroenterology Associates-Site Number: 8400109 — Atlanta, Georgia, United States
Grand Teton Research Group, PLLC-Site Number: 8400127 — Idaho Falls, Idaho, United States
GI Alliance - Gurnee-Site Number: — Gurnee, Illinois, United States
Gastroenterology Health Partners, PLLC - New Albany - Site Number: 8400100 — New Albany, Indiana, United States
University of Kentucky Hospital/UK Albert B. Chandler Hospital-Site Number: 8400058 — Lexington, Kentucky, United States
GI Alliance - Baton Rouge - Site Number: 8400129 — Baton Rouge, Louisiana, United States
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville - Site Number: 8400128 — Mandeville, Louisiana, United States
Delta Research Partners - Site Number: 8400087 — Monroe, Louisiana, United States
UMass Memorial Medical Center-Site Number: 8400121 — Worcester, Massachusetts, United States
Gastroenterology Associates of Western Michigan - Site Number: 8400060 — Wyoming, Michigan, United States
Gateway Gastroenterology - Site Number: 8400097 — Chesterfield, Missouri, United States
BVL Clinical Research - Site Number: 8400005 — Liberty, Missouri, United States
Premier Health Research, LLC-Site Number: 8400114 — Sparta, New Jersey, United States
MedTraits NY - Site Number: 8400045 — Maspeth, New York, United States
NYU Langone Health-Site Number: 8400091 — New York, New York, United States
Weill Cornell Medicine - NewYork-Presbyterian Hospital - Site Number: 8400040 — New York, New York, United States
Lenox Hill Hospital-Site Number: 8400052 — New York, New York, United States
New York Gastroenterology Associates - Site Number: 8400009 — New York, New York, United States
Cross Creek Medical Clinic - Site Number: 8400057 — Fayetteville, North Carolina, United States
Ohio Gastroenterology Group Inc. - Site Number: 8400006 — Columbus, Ohio, United States
North Shore Gastroenterology Research - Site Number: 8400130 — Westlake, Ohio, United States
The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107 — Pittsburgh, Pennsylvania, United States
University Gastroenterology-Site Number: 8400103 — Providence, Rhode Island, United States
One of a Kind Clinical Research Center TX, LLC-Site Number: 8400125 — Kingwood, Texas, United States
GI Alliance - Lubbock - Site Number: 8400092 — Lubbock, Texas, United States
Gastroenterology Research of San Antonio LLC - Site Number: 8400054 — San Antonio, Texas, United States
Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Corporate Office - Site Number: 8400101 — Southlake, Texas, United States
Tyler Research Institute, LLC - Site Number: 8400095 — Tyler, Texas, United States
The Vancouver Clinic Inc. P.S. - Site Number: 8400090 — Vancouver, Washington, United States
Investigational Site Number : 0320007 — Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0360001 — South Brisbane, Australia
Investigational Site Number : 0400003 — Krems, Lower Austria, Austria
Investigational Site Number : 0400002 — Salzburg, Austria
Investigational Site Number : 0560003 — Yvoir, Belgium
Investigational Site Number : 1000003 — Gorna Oryahovitsa, Oblast Veliko Tirnovo, Bulgaria
Investigational Site Number : 1000001 — Sofia, Bulgaria
Investigational Site Number : 1240003 — Toronto, Ontario, Canada
Investigational Site Number : 1240004 — Edmonton, Canada
Investigational Site Number : 1240009 — Hamilton, Canada
Investigational Site Number : 1240013 — London, Canada
Investigational Site Number : 1240006 — New Westminster, Canada
Investigational Site Number : 1520004 — Santiago, Chile
Investigational Site Number : 1520002 — Santiago, Chile
Investigational Site Number : 1520001 — Viña del Mar, Chile
Investigational Site Number : 1560002 — Guangzhou, Guangdong, China
Investigational Site Number : 1560026 — Huizhou, Guangdong, China
Investigational Site Number : 1560018 — Wuxi, Jiangsu, China
Investigational Site Number : 1560001 — Chengdu, Sichuan, China
Investigational Site Number : 1560027 — Beijing, China
Investigational Site Number : 1560028 — Hefei, China
Investigational Site Number : 1560052 — Kunming, China
Investigational Site Number : 1560020 — Shanghai, China
Investigational Site Number : 2030011 — Hradec Králové, Czechia
Investigational Site Number : 2500009 — Amiens, France
Investigational Site Number : 2500008 — Besançon, France
Investigational Site Number : 2500003 — Créteil, France
Investigational Site Number : 2500004 — La Tronche, France
Investigational Site Number : 2500010 — Lille, France
Investigational Site Number : 2500012 — Marseille, France
Investigational Site Number : 2500007 — Nantes, France
Investigational Site Number : 2500013 — Nice, France
Investigational Site Number : 2500001 — Paris, France
Investigational Site Number : 2500002 — Saint-Priest-en-Jarez, France
Investigational Site Number : 2500011 — Toulouse, France
Investigational Site Number : 2500006 — Vandœuvre-lès-Nancy, France
Investigational Site Number : 2680007 — Kutaisi, Georgia
Investigational Site Number : 2680006 — Tbilisi, Georgia
Investigational Site Number : 2680008 — Tbilisi, Georgia
Investigational Site Number : 2680003 — Tbilisi, Georgia
Investigational Site Number : 2680002 — Tbilisi, Georgia
Investigational Site Number : 2680005 — Tbilisi, Georgia
Investigational Site Number : 2680009 — Tbilisi, Georgia
Investigational Site Number : 2760009 — Tübingen, Baden-Wurttemberg, Germany
Investigational Site Number : 2760005 — Ulm, Baden-Wurttemberg, Germany
Investigational Site Number : 2760015 — Leipzig, Saxony, Germany
Investigational Site Number : 2760011 — Halle, Saxony-Anhalt, Germany
Investigational Site Number : 2760001 — Kiel, Schleswig-Holstein, Germany
Investigational Site Number : 2760003 — Berlin, Germany
Investigational Site Number : 2760010 — Minden, Germany
Investigational Site Number : 3000002 — Athens, Greece
Investigational Site Number : 3480004 — Budapest, Hungary
Investigational Site Number : 3480002 — Budapest, Hungary
Investigational Site Number : 3480001 — Veszprém, Hungary
Investigational Site Number : 3760001 — Jerusalem, Israel
Investigational Site Number : 3760002 — Tel Aviv, Israel
Investigational Site Number : 3800009 — Rome, Italy
Investigational Site Number : 3800003 — Rozzano, Italy
Investigational Site Number : 3800005 — Turin, Italy
Investigational Site Number : 3920059 — Bunkyō City, Japan
Investigational Site Number : 3920039 — Chikushino-shi, Japan
Investigational Site Number : 3920031 — Hachiōji, Japan
Investigational Site Number : 3920049 — Kagoshima, Japan
Investigational Site Number : 3920030 — Kamakura, Japan
Investigational Site Number : 3920018 — Kashiwa, Japan
Investigational Site Number : 3920019 — Kobe, Japan
Investigational Site Number : 3920033 — Kōriyama, Japan
Investigational Site Number : 3920051 — Kumamoto, Japan
Investigational Site Number : 3920007 — Minato, Japan
Investigational Site Number : 3920041 — Nagaoka, Japan
Investigational Site Number : 3920013 — Nishinomiya, Japan
Investigational Site Number : 3920002 — Osaka, Japan
Investigational Site Number : 3920014 — Saga, Japan
Investigational Site Number : 3920029 — Sapporo, Japan
Investigational Site Number : 3920042 — Sapporo, Japan
Investigational Site Number : 3920003 — Sendai, Japan
Investigational Site Number : 3920055 — Takamatsu, Japan
Investigational Site Number : 3920057 — Takamatsu, Japan
Investigational Site Number : 3920032 — Toyama, Japan
Investigational Site Number : 3920015 — Toyohashi, Japan
Investigational Site Number : 3920009 — Tsu, Japan
Investigational Site Number : 3920035 — Yokohama, Japan
Investigational Site Number : 4400001 — Kaunas, Lithuania
Investigational Site Number : 4400002 — Panevezys, Lithuania
Investigational Site Number : 4980004 — Chisinau, Moldova
Investigational Site Number : 5280002 — Amsterdam, Netherlands
Investigational Site Number : 6160026 — Bydgoszcz, Poland
Investigational Site Number : 6160019 — Bydgoszcz, Poland
Investigational Site Number : 6160013 — Elblag, Poland
Investigational Site Number : 6160014 — Katowice, Poland
Investigational Site Number : 6160022 — Krakow, Poland
Investigational Site Number : 6160030 — Kłodzko, Poland
Investigational Site Number : 6160034 — Lublin, Poland
Investigational Site Number : 6160010 — Opole, Poland
Investigational Site Number : 6160018 — Poznan, Poland
Investigational Site Number : 6160025 — Rzeszów, Poland
Investigational Site Number : 6160004 — Sopot, Poland
Investigational Site Number : 6160007 — Staszów, Poland
Investigational Site Number : 6160002 — Szczecin, Poland
Investigational Site Number : 6160020 — Szczecin, Poland
Investigational Site Number : 6160023 — Torun, Poland
Investigational Site Number : 6160012 — Wadowice, Poland
Investigational Site Number : 6160005 — Warsaw, Poland
Investigational Site Number : 6160008 — Warsaw, Poland
Investigational Site Number : 6160006 — Wroclaw, Poland
Investigational Site Number : 6160028 — Wroclaw, Poland
Investigational Site Number : 6160017 — Wroclaw, Poland
Investigational Site Number : 6880001 — Belgrade, Serbia
Investigational Site Number : 6880002 — Belgrade, Serbia
Investigational Site Number : 6880007 — Belgrade, Serbia
Investigational Site Number : 7030003 — Košice, Slovakia
Investigational Site Number : 7030002 — Prešov, Slovakia
Investigational Site Number : 7030004 — Prešov, Slovakia
Investigational Site Number : 7100002 — Cape Town, South Africa
Investigational Site Number : 7100005 — Claremont, South Africa
Investigational Site Number : 7100004 — Durban, South Africa
Investigational Site Number : 4100010 — Ansan-si, South Korea
Investigational Site Number : 4100008 — Busan, South Korea
Investigational Site Number : 4100004 — Daegu, South Korea
Investigational Site Number : 4100006 — Seoul, South Korea
Investigational Site Number : 4100005 — Suwon, South Korea
Investigational Site Number : 7240002 — Huelva, Spain
Investigational Site Number : 7560001 — Bern, Switzerland
Investigational Site Number : 1580001 — Taoyuan City, Taiwan
Investigational Site Number : 8040003 — Chernivtsi, Ukraine
Investigational Site Number : 8040001 — Kyiv, Ukraine
Investigational Site Number : 8040002 — Kyiv, Ukraine
Investigational Site Number : 8040004 — Lviv, Ukraine
Investigational Site Number : 8040005 — Lviv, Ukraine
Investigational Site Number : 8040006 — Uzhhorod, Ukraine
Investigational Site Number : 8040010 — Vinnytsia, Ukraine
Investigational Site Number : 8040009 — Vinnytsia, Ukraine
Investigational Site Number : 8040008 — Vinnytsia, Ukraine
Investigational Site Number : 8260001 — London, United Kingdom

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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