An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
SUNSCAPE-1
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.
2 other identifiers
interventional
980
20 countries
191
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2025
Typical duration for phase_3
191 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2025
CompletedFirst Posted
Study publicly available on registry
September 22, 2025
CompletedStudy Start
First participant enrolled
October 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 9, 2028
April 24, 2026
April 1, 2026
2.6 years
September 15, 2025
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Week 12
Secondary Outcomes (16)
Proportion of participants who achieve endoscopic improvement.
Week 12
Proportion of participants achieving clinical response by modified Mayo Score (mMS).
Week 12
Proportion of participants achieving histological endoscopic mucosal improvement.
Week 12
Change from baseline in PROMIS-Fatigue Short Form 7a T-score.
Baseline, Week 12
Proportion of participants with symptomatic (SFS and RBS) remission
Week 12
- +11 more secondary outcomes
Study Arms (3)
Duvakitug - dose 1
EXPERIMENTALSubcutaneous (SC) injection as per protocol
Duvakitug - dose 2
EXPERIMENTALSC injection as per protocol
Placebo
PLACEBO COMPARATORSC injection as per protocol
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
- Teva Branded Pharmaceutical Products R&D LLCcollaborator
Study Sites (191)
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2025
First Posted
September 22, 2025
Study Start
October 8, 2025
Primary Completion (Estimated)
May 9, 2028
Study Completion (Estimated)
May 9, 2028
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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