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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
2026-06-22
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 (35)
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
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
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
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
GI Alliance - Lubbock-Site Number: 8400092
Lubbock, Texas, United States
Gastroenterology Research of San Antonio LLC-Site Number: 8400054
San Antonio, Texas, United States
Tyler Research Institute LLC-Site Number: 8400095
Tyler, Texas, United States
Gastroenterology Associates of Western Michigan-Site Number: 8400060
Wyoming, Wyoming, United States
Investigational Site Number : 1240009
Hamilton, Canada
Investigational Site Number : 1240003
Toronto, Canada
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 : 3920009
Tsu, Japan
Investigational Site Number : 4980003
Chisinau, Moldova
Investigational Site Number : 4980004
Chisinau, Moldova
Investigational Site Number : 7100001
Kempton Park, South Africa
Investigational Site Number : 8040005
Lviv, Ukraine
Investigational Site Number : 8040010
Vinnytsia, Ukraine
Investigational Site Number : 8040009
Vinnytsia, Ukraine