A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Start Date
1/16/2026
Completion Date
4/28/2033
Summary
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.
Eligibility Criteria
Age Range: 16 years to 80 years
Interventions
Duvakitug
Placebo
Conditions
Locations
Del Sol Research Management, LLC - Site Number: 8400012
Tucson, Arizona 85715
United States
Southern California GI & Liver Centers - Site Number: 8400062
Coronado, California 92118
United States
United Medical Doctors CA - Site Number: 8400044
Murrieta, California 92563
United States
Om Research, LLC - Victorville - Site Number: 8400022
Victorville, California 92395
United States
Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039
Colorado Springs, Colorado 80907
United States
Royal Palm Clinical Research - Site Number: 8400065
Fort Myers, Florida 33901
United States
Clinical Research of Osceola - Site Number: 8400013
Kissimmee, Florida 34741
United States
Bioresearch Partner-Kendale Lakes - Site Number: 8400053
Miami, Florida 33155
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
Delta Research Partners - Site Number: 8400087
Monroe, Louisiana 71291
United States
Gastroenterology Associates of Western Michigan - Site Number: 8400060
Wyoming, Michigan 49519
United States
Gateway Gastroenterology - Site Number: 8400097
Chesterfield, Missouri 63017
United States
BVL Clinical Research - Site Number: 8400005
Liberty, Missouri 64068
United States
MedTraits NY - Site Number: 8400045
Maspeth, New York 11378
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
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
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
Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Corporate Office - Site Number: 8400101
Southlake, Texas 76092
United States
Tyler Research Institute, LLC - Site Number: 8400095
Tyler, Texas 75701
United States
The Vancouver Clinic Inc. P.S. - Site Number: 8400090
Vancouver, Washington 98664
United States
Investigational Site Number : 1240003
Toronto, Ontario M6A 3B4
Canada
Charlton Digestive Disease Centre - Site Number : 1240009
Hamilton, L8N 1Y2
Canada
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC - Site Number : 2680002
Tbilisi, 0180
Georgia
Tokai University Hachioji Hospital - Site Number : 3920031
Hachiōji, 192-0032
Japan
Investigational Site Number : 3920049
Kagoshima, 892-0843
Japan
Investigational Site Number : 3920030
Kamakura, 247-0056
Japan
Investigational Site Number : 3920019
Kobe, 650-0015
Japan
Investigational Site Number : 3920029
Sapporo, 004-0041
Japan
Investigational Site Number : 3920009
Tsu, 514-8507
Japan
Investigational Site Number : 4400002
Panevezys, 35144
Lithuania
SONOMED - Site Number : 6160020
Szczecin, 71-685
Poland
Investigational Site Number : 6880001
Belgrade, 11,000
Serbia
Investigational Site Number : 6880002
Belgrade, 11000
Serbia
Investigational Site Number : 8040001
Kyiv, 2002
Ukraine
Investigational Site Number : 8040002
Kyiv, 3037
Ukraine
Investigational Site Number : 8040005
Lviv, 79019
Ukraine
Investigational Site Number : 8040006
Uzhhorod, 88018
Ukraine
Investigational Site Number : 8040008
Vinnytsia, 21029
Ukraine