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A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Sponsor: Sanofi
Summary
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
Official title: A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Key Details
Gender
All
Age Range
16 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
751
Start Date
2026-01-22
Completion Date
2034-03-20
Last Updated
2026-09-23
Healthy Volunteers
No
Conditions
Interventions
Duvakitug
Pharmaceutical form:Injection solution-Route of administration:SC injection
Placebo
Pharmaceutical form:Injection solution-Route of administration:SC injection
Locations (90)
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