RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Sanofi • ClinicalTrials.gov ID: NCT07184944

Registry updated: 2026-09-23

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Description

This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). 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 the Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 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 STARSCAPE-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 patient's potential participation in a clinical trial

Conditions

Crohn's Disease

Locations

Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039 — Colorado Springs, Colorado, United States
Clinical Research of Osceola-Site Number: 8400013 — Kissimmee, Florida, United States
Columbus Clinical Services LLc-Site Number: 8400038 — Miami, Florida, United States
Bioresearch Partner-Kendale Lakes-Site Number: 8400053 — Miami, Florida, United States
Orlando Health, Inc., Digestive Health Institute-Site Number: 8400084 — Orlando, Florida, United States
NMC Research LLC-Site Number: 8400033 — Tampa, Florida, United States
Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee-Site Number: 8400049 — Gurnee, Illinois, United States
Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100 — New Albany, Indiana, 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
GI Alliance - Metairie-Site Number: 8400124 — Metairie, Louisiana, United States
Delta Research Partners-Site Number: 8400087 — Monroe, Louisiana, United States
BVL Clinical Research-Site Number: 8400005 — Liberty, Missouri, United States
Gateway Gastroenterology-Site Number: 8400097 — St Louis, Missouri, 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
New York Gastroenterology Associates-Site Number: 8400009 — New York, New York, United States
UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074 — Chapel Hill, North Carolina, 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
Medical Associates Research Group-Site Number: 8400063 — Columbus, Ohio, United States
OSU Wexner Medical Center-Site Number: 8400077 — Columbus, Ohio, United States
North Shore Gastroenterology Research-Site Number: 8400130 — Westlake, Ohio, United States
University of Pennsylvania School of Medicine-Site Number: 8400072 — Philadelphia, Pennsylvania, United States
The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107 — Pittsburgh, Pennsylvania, United States
University Gastroenterology - GI Alliance-Site Number: 8400103 — Providence, Rhode Island, United States
GI Alliance - Lubbock-Site Number: 8400092 — Lubbock, Texas, United States
SMS Clinical Research-Site Number: 8400035 — Mesquite, 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-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
Gastroenterology Associates of Western Michigan-Site Number: 8400060 — Wyoming, Wyoming, United States
Investigational Site Number : 0360001 — South Brisbane, Queensland, Australia
Investigational Site Number : 0400002 — Salzburg, Australia
Investigational Site Number : 0400007 — Vienna, Australia
Investigational Site Number : 0560003 — Yvoir, Belgium
Sao Jose do Rio Preto Regional Faculty of Medicine Foundation-Site Number: 0760006 — São José do Rio Preto, Brazil
Investigational Site Number : 1000007 — Rousse, Bulgaria
Investigational Site Number : 1000001 — Sofia, Bulgaria
Investigational Site Number : 1240009 — Hamilton, Canada
Investigational Site Number : 1240013 — London, Canada
Investigational Site Number : 1240006 — New Westminster, Canada
Investigational Site Number : 1240003 — Toronto, Canada
Investigational Site Number : 1560002 — Guangzhou, China
Investigational Site Number : 1560026 — Huizhou, China
Investigational Site Number : 1560020 — Shanghai, China
Investigational Site Number : 1560018 — Wuxi, China
Investigational Site Number: 2030011 — Hradec Králové, Czechia
Investigational Site Number : 2030013 — Prague, Czechia
Investigational Site Number : 2680006 — Tbilisi, Georgia
Investigational Site Number : 2680008 — Tbilisi, Georgia
Investigational Site Number : 2680003 — Tbilisi, Georgia
Investigational Site Number : 2680005 — Tbilisi, Georgia
Investigational Site Number : 2680002 — Tbilisi, Georgia
Investigational Site Number : 2680004 — Tbilisi, Georgia
Investigational Site Number : 2760005 — Ulm, Baden-Wurttemberg, Germany
Investigational Site Number : 3760001 — Jerusalem, Israel
Investigational Site Number : 3760002 — Tel Aviv, Israel
Investigational Site Number : 3800003 — Rozzano, Italy
Investigational Site Number : 3800005 — Turin, Italy
Investigational Site Number : 3920030 — Kamakura, Japan
Investigational Site Number : 3920013 — Nishinomiya, Japan
Investigational Site Number : 3920009 — Tsu, Japan
Investigational Site Number : 4980002 — Chisinau, Moldova
Investigational Site Number : 4980003 — Chisinau, Moldova
Investigational Site Number : 4980004 — Chisinau, Moldova
Investigational Site Number : 5540003 — Lower Hutt, New Zealand
Investigational Site Number : 6160026 — Bydgoszcz, Poland
Investigational Site Number : 6160030 — Kłodzko, Poland
Investigational Site Number : 6160034 — Lublin, Poland
Investigational Site Number : 6160007 — Staszów, Poland
Investigational Site Number : 6160020 — Szczecin, Poland
Investigational Site Number : 6160008 — Warsaw, Poland
Investigational Site Number : 6880002 — Belgrade, Serbia
Investigational Site Number : 7100004 — Durban, South Africa
Investigational Site Number : 7100001 — Kempton Park, South Africa
Investigational Site Number : 4100008 — Busan, South Korea
Investigational Site Number : 4100007 — Gwangju, South Korea
Investigational Site Number : 4100006 — Seoul, South Korea
Investigational Site Number : 4100002 — Seoul, South Korea
Investigational Site Number : 7560001 — Bern, Switzerland
Investigational Site Number : 1580005 — Changhua County, Taiwan
Investigational Site Number : 8040001 — Kyiv, Ukraine
Investigational Site Number : 8040013 — Kyiv, 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

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Official Source

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

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