Ulcerative ColitisPhase 3SUNSCAPE-1NCT07184996
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study testing Duvakitug in people with Ulcerative Colitis, run by Sanofi at 240 sites in 25 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Duvakitug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 980 participants
- Where
- 240 sitesin 25 countries
- Study dates
- 8 Oct 2025to 9 May 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to <18 years of age who meet the definition of Tanner Stage 5 for development
- Confirmed diagnosis of moderately to severely active UC for at least 3 months prior to Baseline
- Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies
Who cannot join
- Participants with Crohn's Disease (CD), indeterminate colitis
- Current diagnosis of Ulcerative Proctitis
- Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of >3 bowel resections
- Prior or current high-grade gastrointestinal (GI) dysplasia
- Participants on treatment with but not on stable doses of conventional therapies prior to baseline
- Participants with prohibited medications or therapies prior to baseline
- Participants with previous exposure to anti-TL1A investigational therapy The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
240 sites in 25 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
240 sites in 25 countries
United States120 sites, 120 recruiting
- Recruiting
FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027
Arcadia, California, 91006
- Recruiting
Atlanta Gastroenterology Associates - Site Number: 8400109
Atlanta, Georgia, 30342
- Recruiting
UCHealth Digestive Health Center - Anschutz Medical Campus - Site Number: 8400085
Aurora, Colorado, 80045
- Recruiting
Mercy Medical Center, Baltimore - Site Number: 8400117
Baltimore, Maryland, 21202
- Recruiting
GI Alliance - Baton Rouge - Site Number: 8400129
Baton Rouge, Louisiana, 70809
- Recruiting
Inquest Clinical Research - Site Number: 8400144
Baytown, Texas, 77521
- Recruiting
GI Alliance - Bellevue - Site Number: 8400143
Bellevue, Washington, 98004
- Not yet recruiting
Tufts Medical Center - Site Number: 8400126
Boston, Massachusetts, 02111
- Recruiting
Alliance Research Institute - Site Number: 8400008
Canoga Park, California, 91304
- Recruiting
Gastroenterology & Hepatology Specialists, Inc. - Site Number: 8400139
Canton, Ohio, 44718
- Recruiting
UNC Hospitals, The University of North Carolina at Chapel Hill - Site Number: 8400074
Chapel Hill, North Carolina, 27514
- Recruiting
OnSite Clinical Solutions - Site Number: 8400051
Charlotte, North Carolina, 28211
- Recruiting
Gateway Gastroenterology - Site Number: 8400097
Chesterfield, Missouri, 63017
- Recruiting
Rush University Medical Center - Site Number: 8400015
Chicago, Illinois, 60612
- Recruiting
Novum Research, LLC - Site Number: 8400003
Clermont, Florida, 32803
- Recruiting
Iowa Digestive Disease Center - Site Number: 8400134
Clive, Iowa, 50325
- Recruiting
Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039
Colorado Springs, Colorado, 80907
- Recruiting
Ohio Gastroenterology Group Inc. - Site Number: 8400006
Columbus, Ohio, 43202
- Recruiting
OSU Wexner Medical Center - Site Number: 8400077
Columbus, Ohio, 43210
- Recruiting
Precision Clinical Research-Site Number: 8400059
Coral Springs, Florida, 33065
- Recruiting
Gastro One - Cordova-Site Number: 8400158
Cordova, Tennessee, 38018
- Recruiting
Southern California GI & Liver Centers - Site Number: 8400062
Coronado, California, 92118-1408
- Recruiting
The University of Texas Southwestern Medical Center - Site Number: 8400098
Dallas, Texas, 75390
- Recruiting
DSI Research, LLC - Site Number: 8400115
Dayton, Ohio, 45414
- Recruiting
Gastroenterology of the Rockies - Denver - Site Number: 8400122
Denver, Colorado, 80218
- Recruiting
Midwest Digestive Health and Nutrition - Site Number: 8400136
Des Plaines, Illinois, 60016
- Recruiting
Duke University Medical Center - Site Number: 8400093
Durham, North Carolina, 27710
- Recruiting
Sanmora Bespoke Clinical Research Solutions LLC - Site Number: 8400123
East Orange, New Jersey, 07018
- Recruiting
Plains Medical Clinic - Site Number: 8400078
Fargo, North Dakota, 58104
- Recruiting
Cross Creek Medical Clinic - Site Number: 8400057
Fayetteville, North Carolina, 28304
- Recruiting
GMC Clinical Research, LLC - Site Number: 8400113
Folsom, California, 95630
- Recruiting
Allied Health Clinical Research Organization, LLC - Freehold - Site Number: 8400014
Freehold, New Jersey, 07728
- Recruiting
Sarkis Clinical Trials-Ocala - Site Number: 8400048
Gainesville, Florida, 32607
- Recruiting
GI Alliance - Glenview - Site Number: 8400068
Glenview, Illinois, 60026
- Recruiting
Mid-Atlantic GI Research, LLC - Site Number: 8400106
Greenbelt, Maryland, 20770
- Recruiting
Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee - Site Number: 8400049
Gurnee, Illinois, 60031
- Recruiting
Valley Institute of Research - Site Number: 8400004
Harlingen, Texas, 78550
- Recruiting
Penn State Milton S. Hershey Medical Center - Site Number: 8400066
Hershey, Pennsylvania, 17033-0850
- Recruiting
Tandem Intermediate, LLC - Houma -Site Number: 8400034
Houma, Louisiana, 70072
- Recruiting
Grand Teton Research Group, PLLC - Site Number: 8400127
Idaho Falls, Idaho, 83404
- Recruiting
Allied Health Clinical Research Organization, LLC - Jackson - Site Number: 8400007
Jackson, New Jersey, 08527
- Recruiting
University of Kansas Medical Center - Site Number: 8400110
Kansas City, Kansas, 66160
- Recruiting
One of a Kind Clinical Research Center LLC - Texas - Site Number: 8400125
Kingwood, Texas, 77339
- Recruiting
Clinical Research of Osceola - Site Number: 8400013
Kissimmee, Florida, 34741
- Recruiting
Innovare Research Group - Site Number: 8400067
Lake Jackson, Texas, 77566
- Recruiting
Om Research, LLC - Lancaster - Site Number: 8400148
Lancaster, California, 93534
- Recruiting
Las Vegas Clinical Trials - Site Number: 8400079
Las Vegas, Nevada, 89128
- Recruiting
University of Kentucky Hospital/UK Albert B. Chandler Hospital - Site Number: 8400058
Lexington, Kentucky, 40536-0293
- Recruiting
BVL Clinical Research - Site Number: 8400005
Liberty, Missouri, 64068
- Recruiting
Preferred Research Partners - Site Number: 8400018
Little Rock, Arkansas, 72211
- Recruiting
TLC Clinical Research Inc. - Site Number: 8400030
Los Angeles, California, 90048
- Recruiting
Texas Digestive Disease Consultants dba GI Alliance - Lubbock - Site Number: 8400092
Lubbock, Texas, 79410
- Recruiting
Blue Ridge Medical Research - Site Number: 8400020
Lynchburg, Virginia, 24502
- Recruiting
GastroGroup - Site Number: 8400128
Mandeville, Louisiana, 70471
- Recruiting
Tandem Clinical Research - Marrero - Site Number: 8400002
Marrero, Louisiana, 70072
- Recruiting
MedTraits NY - Site Number: 8400045
Maspeth, New York, 11378
- Recruiting
SMS Clinical Research - Site Number: 8400035
Mesquite, Nevada, 75043
- Recruiting
GI Alliance - Metairie - Site Number: 8400124
Metairie, Louisiana, 70006
- Recruiting
Columbus Clinical Services LLc - Site Number: 8400038
Miami, Florida, 33125
- Recruiting
Regis Clinical Research, LLC - Site Number: 8400041
Miami, Florida, 33126
- Recruiting
Sylvester Comprehensive Cancer Center - A University of Miami Hospital and Clinics Facility - Miami - Site Number: 8400111
Miami, Florida, 33136
- Recruiting
Bio Research Partner - Site Number: 8400053
Miami, Florida, 33155
- Recruiting
Medical Professional Clinical Research Center - Site Number: 8400119
Miami, Florida, 33165
- Recruiting
Paradisus Med Research - Site Number: 8400036
Miami, Florida, 33185
- Recruiting
Correa Research Center-Site Number: 8400010
Miami, Florida, 33186
- Recruiting
Delta Research Partners
Monroe, Louisiana, 71291
- Recruiting
Monroe Biomedical Research - Site Number: 8400046
Monroe, North Carolina, 28112
- Recruiting
Atlantic Health System, Morristown Medical Center-Site Number: 400137
Morristown, New Jersey, 07960
- Recruiting
United Medical Doctors CA - Site Number: 8400044
Murrieta, California, 92563
- Recruiting
Gastroenterology Health Partners, PLLC - Site Number: 8400100
New Albany, Indiana, 47150
- Recruiting
Yale University Digestive Disease - Site Number: 8400108
New Haven, Connecticut, 06510
- Recruiting
Care Access - New Iberia - Site Number: 8400031
New Iberia, Louisiana, 70560
- Recruiting
Manhattan Clinical Research, LLC - Site Number: 8400069
New York, New York, 10016
- Recruiting
NYU Langone Health - Site Number: 8400091
New York, New York, 10016
- Recruiting
Weill Cornell Medical College - NewYork-Presbyterian Hospital - Site Number: 8400040
New York, New York, 10065
- Recruiting
Lenox Hill Hospital - Site Number: 8400052
New York, New York, 10075
- Recruiting
New York Gastroenterology Associates - Site Number: 8400009
New York, New York, 10075
- Recruiting
Central Sooner Research - Site Number: 8400094
Norman, Oklahoma, 73071
- Recruiting
Orlando Health, Inc. - Site Number: 8400084
Orlando, Florida, 32806
- Recruiting
AdventHealth Orlando - Site Number: 8400070
Orlando, Florida, 90067
- Recruiting
Om Research, LLC - Oxnard - Site Number: 8400150
Oxnard, California, 93030
- Recruiting
Tropical Clinical Trials - Site Number: 8400082
Palmetto Bay, Florida, 33176
- Recruiting
Onyx Clinical Research - Site Number: 8400021
Peoria, Arizona, 85381
- Recruiting
University of Pennsylvania School of Medicine - Site Number: 8400072
Philadelphia, Pennsylvania, 19104-6243
- Recruiting
The Allegheny Health Network (AHN) Center for Digestive Health - Site Number: 8400107
Pittsburgh, Pennsylvania, 15212
- Recruiting
Oregon Health & Science University, Center for Health and Healing 2 - Site Number: 8400131
Portland, Oregon, 97239-3098
- Recruiting
University Gastroenterology - GI Alliance - Site Number: 8400103
Providence, Rhode Island, 02904
- Recruiting
ClinTrial Research, LLC - Site Number: 8400043
Raleigh, North Carolina, 27612
- Recruiting
Clinical Research Partners - Site Number: 8400080
Richmond, Virginia, 23226
- Recruiting
UC Davis Health System - Site Number: 8400071
Sacramento, California, 95817
- Recruiting
Gastroenterology Research of San Antonio LLC - Site Number: 8400054
San Antonio, Texas, 78229
- Recruiting
Clinical Applications Laboratories Inc - Site Number: 8400056
San Diego, California, 92103
- Recruiting
Medical Associates Research Group - Site Number: 8400063
San Diego, California, 92123
- Recruiting
M3 Wake Research - Atlanta - Site Number: 8400028
Sandy Springs, Georgia, 30328
- Recruiting
Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025
Santa Maria, California, 93458
- Recruiting
One of a Kind Clinical Research Center LLC - Site Number: 8400061
Scottsdale, Arizona, 85258
- Recruiting
Scottsdale Clinical Trials - Site Number: 8400145
Scottsdale, Arizona, 85260
- Recruiting
EBGS Clinical Research Center, LLC - Site Number: 8400037
Snellville, Georgia, 30078
- Recruiting
Tandem-Allied Clinical Research - Somers Point - Site Number: 840050
Somers Point, New Jersey, 08244
- Recruiting
Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Site Number: 8400101
Southlake, Texas, 76092
- Recruiting
Premier Health Research, LLC - Site Number: 8400114
Sparta, New Jersey, 07871
- Recruiting
DSI Research, LLC - Site Number: 8400105
Springboro, Ohio, 45066
- Recruiting
Atlanta Gastroenterology Specialists - Site Number: 8400149
Suwanee, Georgia, 30024
- Recruiting
NMC Research LLC - Site Number: 8400033
Tampa, Florida, 33607
- Recruiting
Valiance Clinical Research - Tarzana - Site Number: 8400023
Tarzana, California, 91356
- Recruiting
Montefiore Medical Center - Bronx - Site Number. 8400142
The Bronx, New York, 10467
- Recruiting
Clinical Trials Management Services - Site Number: 8400047
Thousand Oaks, California, 91360
- Recruiting
University of Toledo Medical Center - Site Number: 8400042
Toledo, Ohio, 43614
- Recruiting
Texas Gastro Consultants - Site Number: 8400029
Tomball, Texas, 77375
- Recruiting
Del Sol Research Management, LLC - Site Number: 8400012
Tucson, Arizona, 85715
- Recruiting
Tyler Research Institute, LLC - Site Number: 8400095
Tyler, Texas, 75701
- Recruiting
Amicis Research Center-Valencia -Site Number: 8400064
Valencia, California, 91355
- Recruiting
The Vancouver Clinic Inc. P.S. - Site Number: 8400090
Vancouver, Washington, 98664
- Recruiting
Om Research, LLC - Victorville - Site Number: 8400022
Victorville, California, 92395
- Recruiting
Cedar Valley Digestive Health Center - Site Number: 8400096
Waterloo, Iowa, 50701
- Recruiting
Biocentric Health Research Partner
West Columbia, South Carolina, 29169
- Recruiting
Velocity Clinical Research, Salt Lake City - Site Number: 8400147
West Jordan, Utah, 84088
- Recruiting
North Shore Gastroenterology Research - Site Number: 8400130
Westlake, Ohio, 44145
- Recruiting
UMass Memorial Medical Center - Site Number: 8400121
Worcester, Massachusetts, 01655
- Recruiting
Gastroenterology Associates of Western Michigan - Site Number: 8400060
Wyoming, Michigan, 49519
Japan33 sites, 33 recruiting
- Recruiting
Asahikawa City Hospital - Site Number : 3920011
Asahikawa, 070-8610
- Recruiting
Investigational Site Number : 3920005
Asahikawa, 078-8510
- Recruiting
The University of Tokyo Hospital - Site Number : 3920059
Bunkyō City, 113-8655
- Recruiting
Investigational Site Number : 3920039
Chikushino-shi, 818-8502
- Recruiting
Investigational Site Number : 3920021
Chūō, 104-0061
- Recruiting
Japanese Red Cross Fukuoka Hospital - Site Number : 3920027
Fukuoka, 815-8555
- Recruiting
Kagoshima IBD Gastroenterology Clinic - Site Number : 3920049
Kagoshima, 892-0843
- Recruiting
Ofuna Chuo Hospital - Site Number : 3920029
Kamakura, 247-0056
- Recruiting
National Hospital Organization Kanazawa Medical Center - Investigational Site Number : 3920010
Kanazawa, 920-8650
- Recruiting
Kokikai Tsujinaka Hospital Kashiwanoha - Site Number : 3920031
Kashiwa, 277-0871
- Recruiting
Aoyama Clinic, Site Number : 3920018
Kobe, 650-0015
- Recruiting
Hattori Clinic - Site Number : 3920051
Kumamoto, 860-0004
- Recruiting
Nagaoka Red Cross Hospital - Site Number : 3920041
Nagaoka, 940-2085
- Recruiting
Investigational Site Number : 3920008
Okayama, 703-8511
- Recruiting
Investigational Site Number : 3920050
Osaka, 532-0003
- Recruiting
National Hospital Organization Osaka National Hospital - Investigational Site Number : 3920002
Osaka
- Recruiting
Public Institution Panevezys Republican hospital - Site Number : 4400002
Panevezys, 35144
- Recruiting
Investigational Site Number : 3920014
Saga, 849-8501
- Recruiting
Investigational Site Number : 3920023
Sakura, 285-8741
- Recruiting
Sapporo Tokushukai Hospital - Site Number : 3920019
Sapporo, 004-0041
- Recruiting
Investigational Site Number : 3920056
Sapporo, 062-8618
- Recruiting
Sapporo Higashi Tokushukai Hospital - Investigational Site Number : 3920042
Sapporo, 065-0033
- Recruiting
Investigational Site Number : 3920048
Sendai, 980-8574
- Recruiting
Takagi Clinic - Site Number : 3920004
Sendai, 981-3213
- Recruiting
National Hospital Organization Sendai Medical Center - Investigational Site Number : 3920003
Sendai
- Recruiting
National Center for Global Health and Medicine - Site Number : 3920038
Shinjuku, 162-8655
- Recruiting
Iwate Medical University Hospital - Site Number : 3920020
Shiwa-gun, 028-3695
- Recruiting
Tokai University Hachioji Hospital - Site Number : 3920030
Tokyo, 192-0032
- Recruiting
Toyama University Hospital - Site Number : 3920032
Toyama, 930-0194
- Recruiting
Toyama Prefectural Central Hospital - Site Number : 3920037
Toyama, 930-8550
- Recruiting
Investigational Site Number : 3920015
Toyohashi, 441-8570
- Recruiting
Mie University Hospital - Investigational Site Number : 3920009
Tsu, 514-8507
- Recruiting
Investigational Site Number : 3920035
Yokohama, 232-0024
Poland15 sites, 15 recruiting
- Recruiting
Investigational Site Number : 6160013
Elblag, 82-300
- Recruiting
Investigational Site Number : 6160014
Katowice, 40-748
- Recruiting
Investigational Site Number : 6160022
Krakow, 31-506
- Recruiting
Investigational Site Number : 6160016
Lodz, 90-752
- Recruiting
Investigational Site Number : 6160018
Poznan, 60-309
- Recruiting
Investigational Site Number : 6160025
Rzeszów, 35-055
- Recruiting
Endoskopia Sp. z o.o. (LLC) - Site Number : 6160004
Sopot, 81-756
- Recruiting
New health-CK, Kieltucki and partners g.p. - Site Number : 6160007
Staszów, 28-200
- Recruiting
Investigational Site Number : 6160002
Szczecin, 71-434
- Recruiting
SONOMED - Site Number : 6160020
Szczecin, 71-685
- Recruiting
Investigational Site Number : 6160012
Wadowice, 34-100
- Recruiting
Investigational Site Number : 6160005
Warsaw, 00-189
- Recruiting
Investigational Site Number : 6160006
Warsaw, 00-189
- Recruiting
Investigational Site Number : 6160031
Warsaw, 01-595
- Recruiting
Investigational Site Number : 6160028
Wrocklaw, 53-611
Ukraine11 sites, 11 recruiting
- Recruiting
Bukovinian State Medical University - Site Number : 8040003
Chernivtsi, 58001
- Recruiting
Limited Liability Company 'Edelweiss Medics' - Site Number : 8040001
Kyiv, 2002
- Recruiting
Investigational Site Number : 8040013
Kyiv, 2091
- Recruiting
Limited Liability Company 'Medbud-Clinic' - Site Number : 8040002
Kyiv, 3037
- Recruiting
University Hospital of the State Non-Profit Enterprise 'Danylo Halytsky Lviv National Medical University' - Site Number : 8040004
Lviv, 79000
- Recruiting
State Non-Profit Enterprise 'Danulo Halytsky National Medical University in Lviv' - Site Number : 8040012
Lviv, 79010
- Recruiting
Limited Liability Company 'PROGASTRO CLINIC' - Site Number : 8040005
Lviv, 79019
- Recruiting
Public Non-Profit Enterprise 'Andrii Novak Zakarpattia Regional Clinical Hospital' under Zakarpattia Regional Council - Site Number : 8040006
Uzhhorod, 88000
- Recruiting
Limited Liability Company 'Center of Gastroenterology and Dietology' - Site Number : 8040010
Vinnytsia, 21013
- Recruiting
National Pirogov Memorial Medical University - Site Number : 8040009
Vinnytsia, 21028
- Recruiting
National Pirogov Memorial Medical University - Site Number : 8040008
Vinnytsia, 21029
Germany9 sites, 9 recruiting
- Recruiting
Investigational Site Number : 2760017
Berlin, 10117
- Recruiting
Investigational Site Number : 2760003
Berlin, 14163
- Recruiting
Investigational Site Number : 2760021
Halle, Saxony-Anhalt, 6120
- Recruiting
Investigational Site Number : 2760026
Herne, 44623
- Recruiting
Investigational Site Number : 2760001
Kiel, 24105
- Recruiting
Investigational Site Number : 2760015
Leipzig, 4103
- Recruiting
Investigational Site Number : 2760010
Minden, 32423
- Recruiting
Investigational Site Number : 2760005
Ulm, 89081
- Recruiting
Investigational Site Number : 2760028
Wolfsburg, Lower Saxony, 38440
China7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 1560017
Changshu, 215523
- Recruiting
Investigational Site Number : 1560001
Chengdu, 610065
- Recruiting
Investigational Site Number : 1560056
Jinhua, 321000
- Recruiting
Investigational Site Number : 1560062
Luoyang, Henan, 471003
- Recruiting
Investigational Site Number : 1560039
Luzhou, 646099
- Recruiting
Investigational Site Number : 1560058
Shanghai, 201318
- Recruiting
Investigational Site Number : 1560003
Wuhan, Hubei, 430060
Georgia7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 2680007
Kutaisi, 4600
- Recruiting
Investigational Site Number : 2680006
Tbilisi, 102
- Recruiting
Investigational Site Number : 2680008
Tbilisi, 144
- Recruiting
Investigational Site Number : 2680005
Tbilisi, 160
- Recruiting
Investigational Site Number : 2680003
Tbilisi, 180
- Recruiting
LLC The First Medical Center - Site Number : 2680004
Tbilisi, 180
- Recruiting
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC - Site Number : 2680002
Tbilisi, 180
Serbia5 sites, 5 recruiting
- Recruiting
Zvezdara University Medical Center, Clinic of Internal Diseases, Clinical Department of Gastroenterology and Hepatology -Site Number : 6880001
Belgrade, 11,000
- Recruiting
Clinical Hospital Center 'Dr. Dragisa Misovic-Dedinje' - Site Number : 6880007
Belgrade, 11000
- Recruiting
University Clinical Center of Serbia - Site Number : 6880006
Belgrade, 11000
- Recruiting
Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine, Department of Gastroenterology and Hepatology -Site Number : 6880002
Belgrade, 11080
- Recruiting
Investigational Site Number : 6880004
Niš, 18000
Bulgaria3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 1000007
Rusa, 7002
- Recruiting
Investigational Site Number : 1000008
Sofia, 1343
- Recruiting
Investigational Site Number : 1000001
Sofia, 1618
Canada3 sites, 3 recruiting
- Recruiting
Charlton Digestive Disease Centre - Site Number : 1240009
Hamilton, L8N 1Y2
- Recruiting
Oakville Endoscopy Center Inc. DBA ABP Research Services Corp. - Site Number : 1240010
Oakville, L6L 5L7
- Recruiting
Toronto Immune and Digestive Health Institute Inc. (TIDHI) - Site Number : 1240003
Toronto, M6A 3B4
France3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 2500010
Lille, 59000
- Recruiting
Investigational Site Number : 2500013
Nice, 6200
- Recruiting
Investigational Site Number : 2500006
Vandœuvre-lès-Nancy, 54511
Moldova3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 4980003
Chisinau, MD-2025
- Recruiting
PMSI 'Timofei Mosneaga' Republican Clinical Hospital - Site Number : 4980002
Chisinau, MD-2025
- Recruiting
'Sfanta Treime' Municipal Clinical Hospital - Site Number : 4980004
Chisinau, MD-2068
South Africa3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 7100005
Claremont, 7708
- Recruiting
Investigational Site Number : 7100004
Durban, 3610
- Recruiting
Investigational Site Number : 7100001
Kempton Park, 1619
Australia2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 0360004
Liverpool, 2170
- Recruiting
Investigational Site Number : 0360007
Wollongong, 2500
Czechia2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 2030003
Brno, 615 00
- Recruiting
Investigational Site Number : 2030011
Hradec Králové, 500 12
Hungary2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 3480004
Budapest, 1066
- Recruiting
Investigational Site Number : 3480005
Eger, H-3300
Italy2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 3800007
Legnano, 20025
- Recruiting
Investigational Site Number : 3800002
Milan, 20132
Puerto Rico2 sites, 2 recruiting
- Recruiting
Puerto Rico Health and Wellness Institute - Site Number: 8400104
Dorado, 00646
- Recruiting
Wellness Clinical Research - Vega Baja - Site Number: 8400099
Vega Baja, 00693
Taiwan2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 1580003
Chiayi City, 60002
- Recruiting
National Taiwan University Hospital - Site Number : 1580002
Taipei, 100226
Argentina1 site, 1 recruiting
- Recruiting
Investigational Site Number : 0320004
Córdoba, X5016KEH
Austria1 site, 1 recruiting
- Recruiting
Investigational Site Number : 0400008
Vienna, 1160
Lithuania1 site, 1 recruiting
- Recruiting
Investigational Site Number : 4400001
Kaunas, LT-50161
Netherlands1 site, 1 recruiting
- Recruiting
Investigational Site Number : 5280001
Nijmegen, 6525GA
Slovakia1 site, 1 recruiting
- Recruiting
Investigational Site Number : 7030001
Bratislava, 811 09
Switzerland1 site, 1 recruiting
- Recruiting
Investigational Site Number : 7560001
Bern, 3012
About this study
Official title: A Multicenter, Multinational, 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.
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:
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- 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.
- Conditions
- Ulcerative Colitis
- Being tested
- Duvakitug, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuvakitugDrug
Also called SAR447189
Pharmaceutical form:Solution for Injection-Route of administration:SC injection
PlaceboDrug
Pharmaceutical form:Solution for injection-Route of administration:SC injection
| Study group | Role | What they receive |
|---|---|---|
| Duvakitug - dose 1 | Experimental | Subcutaneous (SC) injection as per protocol Receives: Drug: Duvakitug |
| Duvakitug - dose 2 | Experimental | SC injection as per protocol Receives: Drug: Duvakitug |
| Placebo | Placebo comparator | SC injection as per protocol Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving clinical remission.
Clinical remission is defined as modified Mayo Score (mMS) score of 0 to 2, including SFS of 0 or 1, RBS of 0, and modified Mayo Endoscopic Score (MES) of 0 or 1 (score of 1 modified to exclude friability). mMS is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity.
Measured: Week 12
Secondary outcomes (16)
Proportion of participants who achieve endoscopic improvement.
Endoscopic improvement is defined as MES of 0 or 1 (score of 1 excludes friability). Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Measured: Week 12
Proportion of participants achieving clinical response by modified Mayo Score (mMS).
Clinical response is defined as a decrease from baseline in the mMS of ≥2 points and at least a 30% reduction from baseline, and a decrease in RB subscore of ≥1 or an absolute RB subscore of 0 or 1. mMS is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity.
Measured: Week 12
Proportion of participants achieving histological endoscopic mucosal improvement.
Histological endoscopic mucosal improvement is defined as MES of 0 or 1 without the evidence of friability and Geboes Score ≤3.1. The Geboes score has 6 grades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Measured: Week 12
Change from baseline in PROMIS-Fatigue Short Form 7a T-score.
The PROMIS-Fatigue Short Form 7 is a tool that assessesfatigue severity and its impact on daily functioning over the past week.
Measured: Baseline, Week 12
Proportion of participants with symptomatic (SFS and RBS) remission
Symptomatic remission (SF and RB): stool-frequency sub score (SFS ) of 0 or 1, and rectal bleeding sub score (RBS) of 0.
Measured: Week 12
Proportion of participants with no bowel urgency.
The NRS for bowel urgency is a patient-reported tool designed to measure the severity of bowel urgency-the sudden or immediate need to have a bowel movement-experienced in the past 24 hours. This tool utilizes an 11-point scale for evaluation, where 0 represents "no urgency" and 10 signifies the "worst possible urgency".
Measured: Week 12
Proportion of participants reporting no nocturnal bowel movements.
Measured: Week 12
Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission.
Symptomatic response is defined as ≥30% decrease from baseline in the composite clinical endpoint of the sum of SFS and RBS.
Measured: Week 4
Proportion of participants who achieve endoscopic remission.
Endoscopic remission is defined as mMES of 0.
Measured: Week 12
Proportion of participants with no abdominal pain by Numeric Rating Scale (NRS).
The abdominal pain NRS is a tool to rate the severity of abdominal pain over the past 24 hours using a score of 0 ("no pain") to 10 ("worst possible pain").
Measured: Week 12
Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score.
IBDQ is a tool to the quality of life of individuals suffering from IBD. The total score ranges from 32 to 224, with higher scores correlating to a better quality of life.
Measured: Baseline, Week 12
Proportion of participants with UC-related hospitalization.
Measured: Baseline through Week 12
Proportion of participants achieving clinical remission and no steroid use.
Measured: Week 12
Incidence of Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs), and TEAEs leading to permanent study intervention discontinuation.
Measured: Baseline through 45 days after last dose
Serum concentration of duvakitug measured over time.
Measured: Baseline through Week 12
Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug.
Measured: Baseline through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start8 Oct 2025
- Primary completion9 May 2028 (estimated)
- Study completion9 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 980 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teva Branded Pharmaceutical Products R&D LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184996
- Sponsor's protocol ID
- EFC18325
- Other IDs
- 2025-521035-37, 2025
- Acronym
- SUNSCAPE-1
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org