An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Start Date
10/8/2025
Completion Date
5/9/2028
Summary
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction 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 35 weeks with: * Screening period * 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction) * 12-week Sub-Study 3 (Extended Induction for non-responders) * 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.
Eligibility Criteria
Age Range: 16 years to 80 years
Interventions
Duvakitug
Placebo
Conditions
Locations
Onyx Clinical Research - Site Number: 8400021
Peoria, Arizona 85381
United States
One of a Kind Clinical Research Center LLC - Site Number: 8400061
Scottsdale, Arizona 85258
United States
Del Sol Research Management, LLC - Site Number: 8400012
Tucson, Arizona 85715
United States
Preferred Research Partners - Site Number: 8400018
Little Rock, Arkansas 72211
United States
FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027
Arcadia, California 91006
United States
Alliance Research Institute - Site Number: 8400008
Canoga Park, California 91304
United States
Southern California GI & Liver Centers - Site Number: 8400062
Coronado, California 92118-1408
United States
GMC Clinical Research, LLC - Site Number: 8400113
Folsom, California 95630
United States
TLC Clinical Research Inc. - Site Number: 8400030
Los Angeles, California 90048
United States
United Medical Doctors CA - Site Number: 8400044
Murrieta, California 92563
United States
Medical Associates Research Group - Site Number: 8400063
San Diego, California 92123
United States
Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025
Santa Maria, California 93458
United States
Valiance Clinical Research - Tarzana - Site Number: 8400023
Tarzana, California 91356
United States
Clinical Trials Management Services - Site Number: 8400047
Thousand Oaks, California 91360
United States
Amicis Research Center-Valencia -Site Number: 8400064
Valencia, California 91355
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
Gastroenterology of the Rockies - Denver - Site Number: 8400122
Denver, Colorado 80218
United States
Novum Research, LLC - Site Number: 8400003
Clermont, Florida 32803
United States
Precision Clinical Research-Site Number: 8400059
Coral Springs, Florida 33065
United States
Sarkis Clinical Trials-Ocala - Site Number: 8400048
Gainesville, Florida 32607
United States
Clinical Research of Osceola - Site Number: 8400013
Kissimmee, Florida 34741
United States
Columbus Clinical Services LLc - Site Number: 8400038
Miami, Florida 33125
United States
Regis Clinical Research, LLC - Site Number: 8400041
Miami, Florida 33126
United States
Bio Research Partner - Site Number: 8400053
Miami, Florida 33155
United States
Medical Professional Clinical Research Center - Site Number: 8400119
Miami, Florida 33165
United States
Correa Research Center-Site Number: 8400010
Miami, Florida 33186
United States
Orlando Health, Inc. - Site Number: 8400084
Orlando, Florida 32806
United States
Tropical Clinical Trials - Site Number: 8400082
Palmetto Bay, Florida 33176
United States
NMC Research LLC - Site Number: 8400033
Tampa, Florida 33607
United States
Atlanta Gastroenterology Associates - Site Number: 8400109
Atlanta, Georgia 30342
United States
M3 Wake Research - Atlanta - Site Number: 8400028
Sandy Springs, Georgia 30328
United States
EBGS Clinical Research Center, LLC - Site Number: 8400037
Snellville, Georgia 30078
United States
Grand Teton Research Group, PLLC - Site Number: 8400127
Idaho Falls, Idaho 83404
United States
Midwest Digestive Health and Nutrition - Site Number: 8400136
Des Plaines, Illinois 60016
United States
GI Alliance - Glenview - Site Number: 8400068
Glenview, Illinois 60026
United States
Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee - Site Number: 8400049
Gurnee, Illinois 60031
United States
Gastroenterology Health Partners, PLLC - Site Number: 8400100
New Albany, Indiana 47150
United States
Cedar Valley Digestive Health Center - Site Number: 8400096
Waterloo, Iowa 50701
United States
GI Alliance - Baton Rouge - Site Number: 8400129
Baton Rouge, Louisiana 70809
United States
Tandem Intermediate, LLC - Houma -Site Number: 8400034
Houma, Louisiana 70072
United States
GastroGroup - Site Number: 8400128
Mandeville, Louisiana 70471
United States
Tandem Clinical Research - Marrero - Site Number: 8400002
Marrero, Louisiana 70072
United States
GI Alliance - Metairie - Site Number: 8400124
Metairie, Louisiana 70006
United States
Delta Research Partners
Monroe, Louisiana 71291
United States
Care Access - New Iberia - Site Number: 8400031
New Iberia, Louisiana 70560
United States
Mid-Atlantic GI Research, LLC - Site Number: 8400106
Greenbelt, Maryland 20770
United States
UMass Memorial Medical Center - Site Number: 8400121
Worcester, Massachusetts 01655
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
Las Vegas Clinical Trials - Site Number: 8400079
Las Vegas, Nevada 89128
United States
SMS Clinical Research - Site Number: 8400035
Mesquite, Nevada 75043
United States
Sanmora Bespoke Clinical Research Solutions LLC - Site Number: 8400123
East Orange, New Jersey 07018
United States
Allied Health Clinical Research Organization, LLC - Freehold - Site Number: 8400014
Freehold, New Jersey 07728
United States
Allied Health Clinical Research Organization, LLC - Jackson - Site Number: 8400007
Jackson, New Jersey 08527
United States
Tandem-Allied Clinical Research - Somers Point - Site Number: 840050
Somers Point, New Jersey 08244
United States
Premier Health Research, LLC - Site Number: 8400114
Sparta, New Jersey 07871
United States
MedTraits NY - Site Number: 8400045
Maspeth, New York 11378
United States
Manhattan Clinical Research, LLC - Site Number: 8400069
New York, New York 10016
United States
NYU Langone Health - Site Number: 8400091
New York, New York 10016
United States
Weill Cornell Medical College - 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
OnSite Clinical Solutions - Site Number: 8400051
Charlotte, North Carolina 28211
United States
Cross Creek Medical Clinic - Site Number: 8400057
Fayetteville, North Carolina 28304
United States
Monroe Biomedical Research - Site Number: 8400046
Monroe, North Carolina 28112
United States
ClinTrial Research, LLC - Site Number: 8400043
Raleigh, North Carolina 27612
United States
Plains Medical Clinic - Site Number: 8400078
Fargo, North Dakota 58104
United States
Gastroenterology & Hepatology Specialists, Inc. - Site Number: 8400139
Canton, Ohio 44718
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
DSI Research, LLC - Site Number: 8400115
Dayton, Ohio 45414
United States
DSI Research, LLC - Site Number: 8400105
Springboro, Ohio 45066
United States
North Shore Gastroenterology Research - Site Number: 8400130
Westlake, Ohio 44145
United States
Central Sooner Research - Site Number: 8400094
Norman, Oklahoma 73071
United States
University of Pennsylvania School of Medicine - Site Number: 8400072
Philadelphia, Pennsylvania 19104-6243
United States
The Allegheny Health Network (AHN) Center for Digestive Health - Site Number: 8400107
Pittsburgh, Pennsylvania 15212
United States
University Gastroenterology - GI Alliance - Site Number: 8400103
Providence, Rhode Island 02904
United States
Biocentric Health Research Partner
West Columbia, South Carolina 29169
United States
Valley Institute of Research - Site Number: 8400004
Harlingen, Texas 78550
United States
One of a Kind Clinical Research Center LLC - Texas - Site Number: 8400125
Kingwood, Texas 77339
United States
Innovare Research Group - Site Number: 8400067
Lake Jackson, Texas 77566
United States
Texas Digestive Disease Consultants dba 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 - Site Number: 8400101
Southlake, Texas 76092
United States
Texas Gastro Consultants - Site Number: 8400029
Tomball, Texas 77375
United States
Tyler Research Institute, LLC - Site Number: 8400095
Tyler, Texas 75701
United States
Blue Ridge Medical Research - Site Number: 8400020
Lynchburg, Virginia 24502
United States
Clinical Research Partners - Site Number: 8400080
Richmond, Virginia 23226
United States
The Vancouver Clinic Inc. P.S. - Site Number: 8400090
Vancouver, Washington 98664
United States
Investigational Site Number : 1000007
Rusa, 7002
Bulgaria
Investigational Site Number : 1000008
Sofia, 1343
Bulgaria
Investigational Site Number : 1000001
Sofia, 1618
Bulgaria
Charlton Digestive Disease Centre - Site Number : 1240009
Hamilton, L8N 1Y2
Canada
Oakville Endoscopy Center Inc. DBA ABP Research Services Corp. - Site Number : 1240010
Oakville, L6L 5L7
Canada
Toronto Immune and Digestive Health Institute Inc. (TIDHI) - Site Number : 1240003
Toronto, M6A 3B4
Canada
Investigational Site Number : 1560001
Chengdu, 610065
China
Investigational Site Number : 2030011
Hradec Králové, 500 12
Czechia
Investigational Site Number : 2500010
Lille, 59000
France
Investigational Site Number : 2500013
Nice, 6200
France
Investigational Site Number : 2500006
Vandœuvre-lès-Nancy, 54511
France
Investigational Site Number : 2680007
Kutaisi, 4600
Georgia
Investigational Site Number : 2680006
Tbilisi, 102
Georgia
Investigational Site Number : 2680008
Tbilisi, 144
Georgia
Investigational Site Number : 2680005
Tbilisi, 160
Georgia
Investigational Site Number : 2680003
Tbilisi, 180
Georgia
LLC The First Medical Center - Site Number : 2680004
Tbilisi, 180
Georgia
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC - Site Number : 2680002
Tbilisi, 180
Georgia
Investigational Site Number : 2760003
Berlin, 14163
Germany
Investigational Site Number : 2760026
Herne, 44623
Germany
Investigational Site Number : 2760001
Kiel, 24105
Germany
Investigational Site Number : 2760015
Leipzig, 4103
Germany
Investigational Site Number : 2760010
Minden, 32423
Germany
Investigational Site Number : 2760005
Ulm, 89081
Germany
Investigational Site Number : 3480004
Budapest, 1066
Hungary
Asahikawa City Hospital - Site Number : 3920011
Asahikawa, 070-8610
Japan
Investigational Site Number : 3920005
Asahikawa, 078-8510
Japan
The University of Tokyo Hospital - Site Number : 3920059
Bunkyō City, 113-8655
Japan
Investigational Site Number : 3920039
Chikushino-shi, 818-8502
Japan
Investigational Site Number : 3920021
Chūō, 104-0061
Japan
Japanese Red Cross Fukuoka Hospital - Site Number : 3920027
Fukuoka, 815-8555
Japan
Kagoshima IBD Gastroenterology Clinic - Site Number : 3920049
Kagoshima, 892-0843
Japan
Ofuna Chuo Hospital - Site Number : 3920029
Kamakura, 247-0056
Japan
National Hospital Organization Kanazawa Medical Center - Investigational Site Number : 3920010
Kanazawa, 920-8650
Japan
Kokikai Tsujinaka Hospital Kashiwanoha - Site Number : 3920031
Kashiwa, 277-0871
Japan
Aoyama Clinic, Site Number : 3920018
Kobe, 650-0015
Japan
Hattori Clinic - Site Number : 3920051
Kumamoto, 860-0004
Japan
Nagaoka Red Cross Hospital - Site Number : 3920041
Nagaoka, 940-2085
Japan
Investigational Site Number : 3920008
Okayama, 703-8511
Japan
Investigational Site Number : 3920050
Osaka, 532-0003
Japan
National Hospital Organization Osaka National Hospital - Investigational Site Number : 3920002
Osaka,
Japan
Public Institution Panevezys Republican hospital - Site Number : 4400002
Panevezys, 35144
Japan
Investigational Site Number : 3920014
Saga, 849-8501
Japan
Investigational Site Number : 3920023
Sakura, 285-8741
Japan
Sapporo Tokushukai Hospital - Site Number : 3920019
Sapporo, 004-0041
Japan
Investigational Site Number : 3920056
Sapporo, 062-8618
Japan
Sapporo Higashi Tokushukai Hospital - Investigational Site Number : 3920042
Sapporo, 065-0033
Japan
Takagi Clinic - Site Number : 3920004
Sendai, 981-3213
Japan
National Hospital Organization Sendai Medical Center - Investigational Site Number : 3920003
Sendai,
Japan
National Center for Global Health and Medicine - Site Number : 3920038
Shinjuku, 162-8655
Japan
Iwate Medical University Hospital - Site Number : 3920020
Shiwa-gun, 028-3695
Japan
Tokai University Hachioji Hospital - Site Number : 3920030
Tokyo, 192-0032
Japan
Toyama University Hospital - Site Number : 3920032
Toyama, 930-0194
Japan
Toyama Prefectural Central Hospital - Site Number : 3920037
Toyama, 930-8550
Japan
Investigational Site Number : 3920015
Toyohashi, 441-8570
Japan
Mie University Hospital - Investigational Site Number : 3920009
Tsu, 514-8507
Japan
Investigational Site Number : 3920035
Yokohama, 232-0024
Japan
Investigational Site Number : 4400001
Kaunas, LT-50161
Lithuania
Investigational Site Number : 4980003
Chisinau, MD-2025
Moldova
PMSI 'Timofei Mosneaga' Republican Clinical Hospital - Site Number : 4980002
Chisinau, MD-2025
Moldova
'Sfanta Treime' Municipal Clinical Hospital - Site Number : 4980004
Chisinau, MD-2068
Moldova
Investigational Site Number : 6160013
Elblag, 82-300
Poland
Investigational Site Number : 6160014
Katowice, 40-748
Poland
Investigational Site Number : 6160022
Krakow, 31-506
Poland
Investigational Site Number : 6160016
Lodz, 90-752
Poland
Investigational Site Number : 6160018
Poznan, 60-309
Poland
Investigational Site Number : 6160025
Rzeszów, 35-055
Poland
Endoskopia Sp. z o.o. (LLC) - Site Number : 6160004
Sopot, 81-756
Poland
New health-CK, Kieltucki and partners g.p. - Site Number : 6160007
Staszów, 28-200
Poland
Investigational Site Number : 6160002
Szczecin, 71-434
Poland
SONOMED - Site Number : 6160020
Szczecin, 71-685
Poland
Investigational Site Number : 6160012
Wadowice, 34-100
Poland
Investigational Site Number : 6160005
Warsaw, 00-189
Poland
Investigational Site Number : 6160006
Warsaw, 00-189
Poland
Investigational Site Number : 6160031
Warsaw, 01-595
Poland
Investigational Site Number : 6160028
Wrocklaw, 53-611
Poland
Wellness Clinical Research - Vega Baja - Site Number: 8400099
Vega Baja, 00693
Puerto Rico
Zvezdara University Medical Center, Clinic of Internal Diseases, Clinical Department of Gastroenterology and Hepatology -Site Number : 6880001
Belgrade, 11,000
Serbia
Clinical Hospital Center 'Dr. Dragisa Misovic-Dedinje' - Site Number : 6880007
Belgrade, 11000
Serbia
University Clinical Center of Serbia - Site Number : 6880006
Belgrade, 11000
Serbia
Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine, Department of Gastroenterology and Hepatology -Site Number : 6880002
Belgrade, 11080
Serbia
Investigational Site Number : 6880004
Niš, 18000
Serbia
Investigational Site Number : 7030001
Bratislava, 811 09
Slovakia
Investigational Site Number : 7100005
Claremont, 7708
South Africa
Investigational Site Number : 7100004
Durban, 3610
South Africa
Investigational Site Number : 7100001
Kempton Park, 1619
South Africa
Investigational Site Number : 7560001
Bern, 3012
Switzerland
Investigational Site Number : 1580003
Chiayi City, 60002
Taiwan
National Taiwan University Hospital - Site Number : 1580002
Taipei, 100226
Taiwan
Bukovinian State Medical University - Site Number : 8040003
Chernivtsi, 58001
Ukraine
Limited Liability Company 'Edelweiss Medics' - Site Number : 8040001
Kyiv, 2002
Ukraine
Investigational Site Number : 8040013
Kyiv, 2091
Ukraine
Limited Liability Company 'Medbud-Clinic' - Site Number : 8040002
Kyiv, 3037
Ukraine
University Hospital of the State Non-Profit Enterprise 'Danylo Halytsky Lviv National Medical University' - Site Number : 8040004
Lviv, 79000
Ukraine
State Non-Profit Enterprise 'Danulo Halytsky National Medical University in Lviv' - Site Number : 8040012
Lviv, 79010
Ukraine
Limited Liability Company 'PROGASTRO CLINIC' - Site Number : 8040005
Lviv, 79019
Ukraine
Public Non-Profit Enterprise 'Andrii Novak Zakarpattia Regional Clinical Hospital' under Zakarpattia Regional Council - Site Number : 8040006
Uzhhorod, 88000
Ukraine
Limited Liability Company 'Center of Gastroenterology and Dietology' - Site Number : 8040010
Vinnytsia, 21013
Ukraine
National Pirogov Memorial Medical University - Site Number : 8040009
Vinnytsia, 21028
Ukraine
National Pirogov Memorial Medical University - Site Number : 8040008
Vinnytsia, 21029
Ukraine