A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Start Date
1/22/2026
Completion Date
3/20/2034
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
Eligibility Criteria
Age Range: 16 years to 80 years
Interventions
Duvakitug
Placebo
Conditions
Locations
Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
Colorado Springs, Colorado 80907
United States
Clinical Research of Osceola-Site Number: 8400013
Kissimmee, Florida 34741
United States
Bioresearch Partner-Kendale Lakes-Site Number: 8400053
Miami, Florida 33175
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
Gateway Gastroenterology-Site Number: 8400097
St Louis, Missouri 63141
United States
MedTraits NY-Site Number: 8400045
Maspeth, New York 11378
United States
NYU Langone Health-Site Number: 8400091
New York, New York 10016
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
UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074
Chapel Hill, North Carolina 27514
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
University of Pennsylvania School of Medicine-Site Number: 8400072
Philadelphia, Pennsylvania 19104-6243
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
Tyler Research Institute LLC-Site Number: 8400095
Tyler, Texas 75701
United States
Gastroenterology Associates of Western Michigan-Site Number: 8400060
Wyoming, Wyoming 49519
United States
Investigational Site Number : 1240009
Hamilton, L8N 1Y2
Canada
Investigational Site Number : 1240003
Toronto, M6A 3B4
Canada
Investigational Site Number : 2680008
Tbilisi, 144
Georgia
Investigational Site Number : 2680003
Tbilisi, 159
Georgia
Investigational Site Number : 2680005
Tbilisi, 160
Georgia
Investigational Site Number : 2680002
Tbilisi, 180
Georgia
Investigational Site Number : 3920009
Tsu, 514-8507
Japan
Investigational Site Number : 4980003
Chisinau, MD-2025
Moldova
Investigational Site Number : 4980004
Chisinau, MD-2068
Moldova
Investigational Site Number : 7100001
Kempton Park, 1619
South Africa
Investigational Site Number : 8040005
Lviv, 79019
Ukraine
Investigational Site Number : 8040010
Vinnytsia, 21013
Ukraine
Investigational Site Number : 8040009
Vinnytsia, 21028
Ukraine