Crohn's DiseasePhase 3STARSCAPE-1NCT07184931
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
A Phase 3 study testing Duvakitug in people with Crohn's Disease, run by Sanofi at 461 sites in 36 countries.
Trial summary
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Crohn's Disease
- 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
- 461 sitesin 36 countries
- Study dates
- 1 Oct 2025to 14 May 2029
- 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 Crohn's Disease (CD) for at least 3 months prior to baseline
- Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)
Who cannot join
- Participants with Ulcerative Colitis (UC) or indeterminate colitis
- Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum
- Prior or current high-grade gastrointestinal (GI) dysplasia
- Participants on treatment with but not on stable doses of conventional therapy prior to baseline
- Participants receiving prohibited medications or therapies
- 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
461 sites in 36 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
461 sites in 36 countries
United States127 sites, 127 recruiting
- 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
- 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
Rush University Medical Center-Site Number: 8400015
Chicago, Illinois, 60612
- Recruiting
Novum Research, LLC-Site Number: 8400003
Clermont, Florida, 34711
- Recruiting
University Hospitals Cleveland Medical Center-Site Number: 8400073
Cleveland, Ohio, 44106-5077
- Recruiting
Heartland Medical Research, Inc.-Site Number: 8400134
Clive, Iowa, 50325
- Recruiting
Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
Colorado Springs, Colorado, 80907
- Recruiting
Johns Hopkins University Gastroenterology and Hepatology-Site Number: 8400116
Columbia, South Carolina, 21045
- Recruiting
Biocentric Health Research Center-Site Number: 8400089
Columbia, South Carolina, 29203
- Recruiting
Ohio Gastroenterology Group Inc.-8400006
Columbus, Ohio, 43202
- Recruiting
OSU Wexner Medical Center-Site Number: 8400077
Columbus, Ohio, 43210
- 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 Northridge - Dayton-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
Gastroenterology and Liver Institute - Escondido-Site Number: 8400146
Escondido, California, 92025
- Recruiting
Plains Clinical Research Center-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 - Gainesville-Site Number: 8400048
Gainesville, Florida, 32607
- Recruiting
GI Alliance - Glenview-Site Number: 8400068
Glenview, Illinois, 60026
- Recruiting
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, 70360
- 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, Mississippi, 08527
- Recruiting
University of Kansas Medical Center-Site Number: 8400110
Kansas City, Kansas, 66160
- Recruiting
Tri-Cities Gastroenterology-Site Number: 8400076
Kingsport, Tennessee, 37663
- Recruiting
One of a Kind Clinical Research Center TX, LLC-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, 89030
- Recruiting
Mid-Atlantic GI Research, LLC-Site Number: 8400106
Laurel, Maryland, 20708
- 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
GastroIntestinal Bioscience - Los Angeles-Site Number: 8400019
Los Angeles, California, 90067
- Recruiting
GI Alliance - Lubbock-Site Number: 8400092
Lubbock, Texas, 79410
- Recruiting
Blue Ridge Medical Research-Site Number: 8400020
Lynchburg, Virginia, 24502
- Recruiting
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-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, Texas, 75149
- 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
Medical Professional Clinical Research Center-Site Number: 8400119
Miami, Florida, 33165
- Recruiting
Bioresearch Partner-Kendale Lakes-Site Number: 8400053
Miami, Florida, 33175
- Recruiting
Paradisus Med Research-Site Number: 8400036
Miami, Florida, 33185
- Recruiting
Correa Research Center-Site Number: 8400010
Miami, Florida, 33186
- Recruiting
Froedtert Hospital and the Medical College of Wisconsin-Site Number: 8400081
Milwaukee, Wisconsin, 53226
- Recruiting
Delta Research Partners-Site Number: 8400087
Monroe, Louisiana, 71201
- Recruiting
Monroe Biomedical Research-Site Number: 8400046
Monroe, North Carolina, 28112
- Recruiting
Atlantic Health System, Morristown Medical Center-Site Number: 8400137
Morristown, New Jersey, 07960
- Recruiting
United Medical Doctors CA-Site Number: 8400044
Murrieta, California, 92563
- Recruiting
Gastroenterology Health Partners, PLLC - New Albany-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
Columbia University Medical Center-Site Number: 8400138
New York, New York, 10032
- Recruiting
Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040
New York, New York, 10065
- Recruiting
New York Gastroenterology Associates-Site Number: 8400009
New York, New York, 10075
- Recruiting
Central Sooner Research-Site Number: 8400094
Norman, Oklahoma, 73071
- Recruiting
Henry Ford Medical Center - Columbus-Site Number: 8400118
Novi, Michigan, 48377
- Recruiting
AdventHealth Orlando-Site Number: 8400070
Orlando, Florida, 32803
- Recruiting
Orlando Health, Inc.-Site Number: 8400084
Orlando, Florida, 32806
- 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-Site Number: 8400131
Portland, Oregon, 97239
- Recruiting
University Gastroenterology-Site Number: 8400103
Providence, Rhode Island, 02904
- Recruiting
ClinTrial Research, LLC-Site Number: 8400043
Raleigh, North Carolina, 27612
- Recruiting
Prospective Research Innovations Inc.-Site Number: 8400017
Rancho Cucamonga, California, 91730
- 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
One of a Kind Clinical Research Center AZ, 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: 8400050
Somers Point, New Jersey, 08244
- Recruiting
Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Corporate Office-Site Number: 8400101
Southlake, Texas, 76092
- Recruiting
Premier Health Research, LLC-Site Number: 8400114
Sparta, New Jersey, 07871
- Recruiting
DSI Research - Springboro-Site Number: 8400105
Springboro, Ohio, 45066
- Recruiting
Washington University School of Medicine-Site Number: 8400075
St Louis, Missouri, 63110
- Recruiting
Gateway Gastroenterology-Site Number: 8400097
St Louis, Missouri, 63141
- Recruiting
Precision Clinical Research - Sunrise-Site Number: 8400059
Sunrise, Florida, 33351
- 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
Digestive Health Research Center-Site Number: 8400096
Waterloo, Iowa, 50701
- 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
Japan49 sites, 49 recruiting
- Recruiting
Investigational Site Number : 3920005
Asahikawa, 078-8510
- Recruiting
Investigational Site Number : 3920012
Bunkyō City, 113-8519
- Recruiting
Investigational Site Number : 3920059
Bunkyō City, 113-8655
- Recruiting
Investigational Site Number : 3920039
Chikushino-shi, 818-8502
- Recruiting
Investigational Site Number : 3920045
Fukuoka, 810-0001
- Recruiting
Investigational Site Number : 3920063
Fukuoka, 814-0180
- Recruiting
Investigational Site Number : 3920027
Fukuoka, 815-8555
- Recruiting
Investigational Site Number : 3920031
Hachiōji, 192-0032
- Recruiting
Investigational Site Number : 3920065
Isehara, 259-1193
- Recruiting
Investigational Site Number : 3920028
Isesaki, 372-0817
- Recruiting
Investigational Site Number : 3920049
Kagoshima, 892-0843
- Recruiting
Investigational Site Number : 3920030
Kamakura, 247-0056
- Recruiting
Investigational Site Number : 3920018
Kashiwa, 277-0871
- Recruiting
Investigational Site Number : 3920054
Kitakyushu, 806-8501
- Recruiting
Investigational Site Number : 3920019
Kobe, 650-0015
- Recruiting
Investigational Site Number : 3920060
Kobe, 650-0017
- Recruiting
Investigational Site Number : 3920033
Kōriyama, 963-8563
- Recruiting
Investigational Site Number : 3920036
Kumamoto, 862-0971
- Recruiting
Investigational Site Number : 3920061
Kurume, 830-0011
- Recruiting
Investigational Site Number : 3920052
Maebashi, 371-8511
- Recruiting
Investigational Site Number : 3920058
Minato, 105-8471
- Recruiting
Investigational Site Number : 3920024
Mitaka, 181-8611
- Recruiting
Investigational Site Number : 3920062
Nagakute, 480-1195
- Recruiting
Investigational Site Number : 3920026
Nagoya, 457-8511
- Recruiting
Investigational Site Number : 3920057
Nagoya, 466-8560
- Recruiting
Investigational Site Number : 3920013
Nishinomiya, 663-8501
- Recruiting
Investigational Site Number : 3920025
Okayama, 700-8558
- Recruiting
Investigational Site Number : 3920050
Osaka, 532-0003
- Recruiting
Investigational Site Number : 3920002
Osaka, 540-0006
- Recruiting
Investigational Site Number : 3920022
Osaka, 545-8586
- Recruiting
Investigational Site Number : 3920001
Saga, 840-8571
- Recruiting
Investigational Site Number : 3920014
Saga, 849-8501
- Recruiting
Investigational Site Number : 3920064
Sagamihara, 252-0375
- Recruiting
Investigational Site Number : 3920023
Sakura, 285-8741
- Recruiting
Investigational Site Number : 3920029
Sapporo, 004-0041
- Recruiting
Investigational Site Number : 3920042
Sapporo, 065-0033
- Recruiting
Investigational Site Number : 3920048
Sendai, 980-8574
- Recruiting
Investigational Site Number : 3920004
Sendai, 981-3213
- Recruiting
Investigational Site Number : 3920003
Sendai, 983-8520
- Recruiting
Investigational Site Number : 3920047
Shimotsuga-gun, 321-0293
- Recruiting
Investigational Site Number : 3920034
Shinjuku, 162-8666
- Recruiting
Investigational Site Number : 3920006
Shinjuku, 169-0073
- Recruiting
Investigational Site Number : 3920020
Shiwa-gun, 028-3695
- Recruiting
Investigational Site Number : 3920046
Shizuoka, Hamamatsu, 431-3192
- Recruiting
Investigational Site Number : 3920032
Toyama, 930-0194
- Recruiting
Investigational Site Number : 3920037
Toyama, 930-8550
- Recruiting
Investigational Site Number : 3920015
Toyohashi, 441-8570
- Recruiting
Investigational Site Number : 3920009
Tsu, 514-8507
- Recruiting
Investigational Site Number : 3920035
Yokohama, 232-0024
China38 sites, 38 recruiting
- Recruiting
Investigational Site Number : 1560016
Beijing, 100034
- Recruiting
Investigational Site Number : 1560027
Beijing, 100195
- Recruiting
Investigational Site Number : 1560037
Changsha, Hunan, 410011
- Recruiting
Investigational Site Number : 1560017
Changshu, 215523
- Recruiting
Investigational Site Number : 1560011
Changzhou, 213004
- Recruiting
Investigational Site Number : 1560001
Chengdu, Sichuan, 610041
- Recruiting
Investigational Site Number : 1560061
Chengdu, 610072
- Recruiting
Investigational Site Number : 1560036
Fuzhou, 350004
- Recruiting
Investigational Site Number : 1560034
Guangzhou, Guangdong, 510080
- Recruiting
Investigational Site Number : 1560049
Guangzhou, Guangdong, 510180
- Recruiting
Investigational Site Number : 1560002
Guangzhou, Guangdong, 510655
- Recruiting
Investigational Site Number : 1560009
Guangzhou, 510420
- Recruiting
Investigational Site Number : 1560013
Hangzhou, Zhejiang, 310003
- Recruiting
Investigational Site Number : 1560005
Hangzhou, 310009
- Recruiting
Investigational Site Number : 1560060
Hefei, 230022
- Recruiting
Investigational Site Number : 1560026
Huizhou, Guangdong, 516001
- Recruiting
Investigational Site Number : 1560008
Jinan, 250012
- Recruiting
Investigational Site Number : 1560022
Jingzhou, 434099
- Recruiting
Investigational Site Number : 1560056
Jinhua, 321000
- Recruiting
Investigational Site Number : 1560039
Luzhou, 646099
- Recruiting
Investigational Site Number : 1560030
Mianyang, 621000
- Recruiting
Investigational Site Number : 1560025
Nanjing, Jiangsu, 210006
- Recruiting
Investigational Site Number : 1560004
Nanjing, Jiangsu, 210009
- Recruiting
Investigational Site Number : 1560019
Nanjing, 210000
- Recruiting
Investigational Site Number : 1560024
Nanjing, 210011
- Recruiting
Investigational Site Number : 1560057
Qingdao, 26000
- Recruiting
Investigational Site Number : 1560059
Qingyuan, 511518
- Recruiting
Investigational Site Number : 1560020
Shanghai, 200123
- Recruiting
Investigational Site Number : 1560058
Shanghai, 201318
- Recruiting
Investigational Site Number : 1560043
Shenzhen, Guangdong, 518100
- Recruiting
Investigational Site Number : 1560042
Suzhou, 215004
- Recruiting
Investigational Site Number : 1560029
Taizhou, Zhejiang, 31800
- Recruiting
Investigational Site Number : 1560007
Wenzhou, 325027
- Recruiting
Investigational Site Number : 1560010
Wuhan, Hubei, 430022
- Recruiting
Investigational Site Number : 1560003
Wuhan, Hubei, 430060
- Recruiting
Investigational Site Number : 1560018
Wuxi, Jiangsu, 214023
- Recruiting
Investigational Site Number : 1560006
Xiamen, Fujian, 361004
- Recruiting
Investigational Site Number : 1560050
Yangzhou, 225100
Poland32 sites, 32 recruiting
- Recruiting
Investigational Site Number : 6160026
Bydgoszcz, 85-229
- Recruiting
Investigational Site Number : 6160019
Bydgoszcz, 85-794
- Recruiting
Investigational Site Number : 6160013
Elblag, 82-300
- Recruiting
Investigational Site Number : 6160035
Katowice, 40-040
- Recruiting
Investigational Site Number : 6160014
Katowice, 40-748
- Recruiting
Investigational Site Number : 6160030
Kłodzko, 57-300
- Recruiting
Investigational Site Number : 6160022
Krakow, 31-506
- Recruiting
Investigational Site Number : 6160016
Lodz, 90-752
- Recruiting
Investigational Site Number : 6160011
Lodz, 91-034
- Recruiting
Investigational Site Number : 6160034
Lublin, 20-049
- Recruiting
Investigational Site Number : 6160027
Nowy Targ, 34-400
- Recruiting
Investigational Site Number : 6160032
Olsztyn, 10-684
- Recruiting
Investigational Site Number : 6160010
Opole, 45-819
- Recruiting
Investigational Site Number : 6160018
Poznan, 60-309
- Recruiting
Investigational Site Number : 6160001
Poznan, 60-702
- Recruiting
Investigational Site Number : 6160025
Rzeszów, 35-326
- Recruiting
Investigational Site Number : 6160029
Siedlce, 08-110
- Recruiting
Investigational Site Number : 6160004
Sopot, 81-756
- Recruiting
Investigational Site Number : 6160007
Staszów, 28-200
- Recruiting
Investigational Site Number : 6160002
Szczecin, 71-434
- Recruiting
Investigational Site Number : 6160020
Szczecin, 71-685
- Recruiting
Investigational Site Number : 6160023
Torun, 87-100
- Recruiting
Investigational Site Number : 6160015
Tychy, 43-100
- Recruiting
Investigational Site Number : 6160012
Wadowice, 34-100
- Recruiting
Investigational Site Number : 6160005
Warsaw, 00-189
- Recruiting
Investigational Site Number : 6160031
Warsaw, 01-595
- Recruiting
Investigational Site Number : 6160009
Warsaw, 02-786
- Recruiting
Investigational Site Number : 6160003
Warsaw, 03-712
- Recruiting
Investigational Site Number : 6160008
Warsaw, 04-501
- Recruiting
Investigational Site Number : 6160006
Wroclaw, 52-416
- Recruiting
Investigational Site Number : 6160028
Wroclaw, 53-611
- Recruiting
Investigational Site Number : 6160017
Wroclaw, 54-239
Germany20 sites, 20 recruiting
- Recruiting
Investigational Site Number : 2760017
Berlin, 10117
- Recruiting
Investigational Site Number : 2760006
Berlin, 12559
- Recruiting
Investigational Site Number : 2760003
Berlin, 14163
- Recruiting
Investigational Site Number : 2760019
Dachau, 85221
- Recruiting
Investigational Site Number : 2760008
Dresden, Saxony, 1307
- Recruiting
Investigational Site Number : 2760007
Duisburg, 47055
- Recruiting
Investigational Site Number : 2760021
Halle, Saxony-Anhalt, 6120
- Recruiting
Investigational Site Number : 2760004
Hamburg, 20246
- Recruiting
Investigational Site Number : 2760026
Herne, 44623
- Recruiting
Investigational Site Number : 2760016
Jerichow, Saxony-Anhalt, 39319
- Recruiting
Investigational Site Number : 2760001
Kiel, Schleswig-Holstein, 24105
- Recruiting
Investigational Site Number : 2760015
Leipzig, Saxony, 4103
- Recruiting
Investigational Site Number : 2760020
Leipzig, Saxony, 4103
- Recruiting
Investigational Site Number : 2760014
Ludwigshafen am Rhein, Rhineland-Palatinate, 67067
- Recruiting
Investigational Site Number : 2760029
Lüneburg, 21339
- Recruiting
Investigational Site Number : 2760010
Minden, 32423
- Recruiting
Investigational Site Number : 2760013
Remscheid, North Rhine-Westphalia, 42859
- Recruiting
Investigational Site Number : 2760009
Tübingen, Baden-Wurttemberg, 72076
- Recruiting
Investigational Site Number : 2760005
Ulm, Baden-Wurttemberg, 89081
- Recruiting
Investigational Site Number : 2760023
Würzburg, Bavaria, 97080
Brazil13 sites, 13 recruiting
- Recruiting
Investigational Site Number : 0760008
Aracaju, 49075-000
- Recruiting
Investigational Site Number: 0760002
Barretos, São Paulo, 14784-400
- Recruiting
Investigational Site Number : 0760010
Brasília, 72145-450
- Recruiting
Investigational Site Number : 0760012
Campinas, São Paulo, 13092-133
- Recruiting
Investigational Site Number: 0760003
Caxias do Sul, Rio Grande do Sul, 95070-560
- Recruiting
Investigational Site Number : 0760001
Goiânia, 74535-170
- Recruiting
Investigational Site Number: 0760005
Juiz de Fora, Minas Gerais, 36033-318
- Recruiting
Investigational Site Number : 0760009
Porto Alegre, Rio Grande do Sul, 90035-903
- Recruiting
Investigational Site Number : 0760007
Porto Alegre, 90160-092
- Recruiting
Investigational Site Number : 0760013
Salvador, 41820-020
- Recruiting
Investigational Site Number : 0760006
São José do Rio Preto, Sao Jose Do Rio Preto, Sao Paulo, 15090-000
- Recruiting
Investigational Site Number : 0760014
São Paulo, 01139-000
- Recruiting
Investigational Site Number : 0760011
Teresina, 64049-550
France13 sites, 13 recruiting
- Recruiting
Investigational Site Number : 2500009
Amiens, Cedex 1, 80054
- Recruiting
Investigational Site Number : 2500008
Besançon, 25000
- Recruiting
Investigational Site Number : 2500003
Créteil, 94000
- Recruiting
Investigational Site Number : 2500004
La Tronche, 38700
- Recruiting
Investigational Site Number : 2500010
Lille, 59000
- Recruiting
Investigational Site Number : 2500012
Marseille, 13015
- Recruiting
Investigational Site Number : 2500007
Nantes, 44000
- Recruiting
Investigational Site Number : 2500005
Nantes, 44300
- Recruiting
Investigational Site Number : 2500013
Nice, 6200
- Recruiting
Investigational Site Number : 2500001
Paris, 75018
- Recruiting
Investigational Site Number : 2500002
Saint-Etienne, Cedex 2, 42055
- Recruiting
Investigational Site Number : 2500011
Toulouse, 31400
- Recruiting
Investigational Site Number : 2500006
Vandœuvre-lès-Nancy, 54500
Canada11 sites, 11 recruiting
- Recruiting
Investigational Site Number : 1240014
Brampton, L6S 0C1
- Recruiting
Investigational Site Number : 1240004
Edmonton, T6G 2X8
- Recruiting
Investigational Site Number : 1240005
Greater Sudbury, P3C1X3
- Recruiting
Investigational Site Number : 1240009
Hamilton, L8N 1Y2
- Recruiting
Investigational Site Number : 1240011
London, N6A 5W9
- Recruiting
Investigational Site Number : 1240013
London, N6K 1M6
- Recruiting
Investigational Site Number : 1240002
Montreal, H2X 3E4
- Recruiting
Investigational Site Number : 1240007
Montreal, H4J 1C5
- Recruiting
Investigational Site Number : 1240006
New Westminster, BC V3L 3W4
- Recruiting
Investigational Site Number : 1240010
Oakville, Ontario, L6L 5L7
- Recruiting
Investigational Site Number : 1240003
Toronto, M6A 3B4
Ukraine11 sites, 11 recruiting
- Recruiting
Investigational Site Number : 8040003
Chernivtsi, 58001
- Recruiting
Investigational Site Number : 8040001
Kyiv, 2002
- Recruiting
Investigational Site Number : 8040013
Kyiv, 2091
- Recruiting
Investigational Site Number : 8040002
Kyiv, 3037
- Recruiting
Investigational Site Number : 8040004
Lviv, 79000
- Recruiting
Investigational Site Number : 8040011
Lviv, 79010
- Recruiting
Investigational Site Number : 8040005
Lviv, 79019
- Recruiting
Investigational Site Number : 8040006
Uzhhorod, 88018
- Recruiting
Investigational Site Number : 8040010
Vinnytsia, 21013
- Recruiting
Investigational Site Number : 8040009
Vinnytsia, 21028
- Recruiting
Investigational Site Number : 8040008
Vinnytsia, 21029
South Korea10 sites, 10 recruiting
- Recruiting
Investigational Site Number : 4100010
Ansan-si, 15355
- Recruiting
Investigational Site Number : 4100008
Busan, 48108
- Recruiting
Investigational Site Number : 4100009
Busan, 49241
- Recruiting
Investigational Site Number : 4100004
Daegu, 42415
- Recruiting
Investigational Site Number : 4100003
Daejeon, 34943
- Recruiting
Investigational Site Number : 4100007
Gwangju, 61453
- Recruiting
Investigational Site Number : 4100006
Seoul, 6351
- Recruiting
Investigational Site Number : 4100001
Seoul, 6591
- Recruiting
Investigational Site Number : 4100002
Seoul, 6973
- Recruiting
Investigational Site Number : 4100005
Suwon, 16247
Georgia9 sites, 9 recruiting
- Recruiting
Investigational Site Number : 2680007
Kutaisi, 4600
- Recruiting
Investigational Site Number : 2680006
Tbilisi, 102
- Recruiting
Investigational Site Number : 2680001
Tbilisi, 119
- Recruiting
Investigational Site Number : 2680008
Tbilisi, 144
- Recruiting
Investigational Site Number : 2680003
Tbilisi, 159
- Recruiting
Investigational Site Number : 2680005
Tbilisi, 160
- Recruiting
Investigational Site Number : 2680009
Tbilisi, 178
- Recruiting
Investigational Site Number : 2680002
Tbilisi, 180
- Recruiting
Investigational Site Number : 2680004
Tbilisi, 180
Taiwan9 sites, 9 recruiting
- Recruiting
Investigational Site Number : 1580005
Changhua County, 500209
- Recruiting
Investigational Site Number : 1580003
Chiayi City, 60002
- Recruiting
Investigational Site Number : 1580010
Kaohsiung City, 81362
- Recruiting
Investigational Site Number : 1580006
Kaohsiung City, 833401
- Recruiting
Investigational Site Number : 1580009
New Taipei City, 23561
- Recruiting
Investigational Site Number : 1580008
Tainan, 709
- Recruiting
Investigational Site Number : 1580007
Tainan, 71004
- Recruiting
Investigational Site Number : 1580002
Taipei, 100225
- Recruiting
Investigational Site Number : 1580001
Taoyuan City, 333
Austria8 sites, 8 recruiting
- Recruiting
Investigational Site Number : 0400004
Graz, Styria, 8036
- Recruiting
Investigational Site Number : 0400003
Krems, Lower Austria, 3500
- Recruiting
Investigational Site Number : 0400005
Linz, Upper Austria, 4021
- Recruiting
Investigational Site Number : 0400002
Salzburg, 5020
- Recruiting
Investigational Site Number : 0400006
Sankt Veit an der Glan, Carinthia, 9300
- Recruiting
Investigational Site Number : 0400001
Vienna, 1090
- Recruiting
Investigational Site Number : 0400008
Vienna, 1160
- Recruiting
Investigational Site Number : 0400007
Vienna, 1190
Bulgaria8 sites, 8 recruiting
- Recruiting
Investigational Site Number : 1000003
Gorna Oryahovitsa, Oblast Veliko Tirnovo, 5100
- Recruiting
Investigational Site Number : 1000007
Rousse, 7002
- Recruiting
Investigational Site Number : 1000008
Sofia, 1343
- Recruiting
Investigational Site Number : 1000005
Sofia, 1407
- Recruiting
Investigational Site Number : 1000006
Sofia, 1407
- Recruiting
Investigational Site Number : 1000004
Sofia, 1606
- Recruiting
Investigational Site Number : 1000001
Sofia, 1618
- Recruiting
Investigational Site Number : 1000002
Sofia, 1784
Argentina7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 0320001
Buenos Aires, City of Buenos Aires, 1280AEB
- Recruiting
Investigational Site Number : 0320005
Buenos Aires, 1425
- Recruiting
Investigational Site Number : 0320003
Buenos Aires, 1702
- Recruiting
Investigational Site Number : 0320004
Córdoba, X5016KEH
- Recruiting
Investigational Site Number : 0320002
La Plata, Buenos Aires, B1900AXI
- Recruiting
Investigational Site Number : 0320006
Rosario, Santa Fe Province, 2000
- Recruiting
Investigational Site Number : 0320007
Rosario, Santa Fe Province, 2000
Australia7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 0360005
Birtinya, 4575
- Recruiting
Investigational Site Number : 0360003
Clayton, 3168
- Recruiting
Investigational Site Number : 0360004
Liverpool, 2170
- Recruiting
Investigational Site Number : 0360006
Nedlands, 6009
- Recruiting
Investigational Site Number : 0360001
South Brisbane, 4101
- Recruiting
Investigational Site Number : 0360002
Southport, 4215
- Recruiting
Investigational Site Number : 0360007
Wollongong, 2500
Israel7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 3760004
Afula, 1834111
- Recruiting
Investigational Site Number : 3760006
Ashkelon, 7830604
- Recruiting
Investigational Site Number : 3760003
Beersheba, 8410101
- Recruiting
Investigational Site Number : 3760001
Jerusalem, 91004
- Recruiting
Investigational Site Number : 3760005
Nahariya, 2210001
- Recruiting
Investigational Site Number : 3760007
Petah Tikva, 49100
- Recruiting
Investigational Site Number : 3760002
Tel Aviv, 6423906
Netherlands7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 5280002
Amsterdam, 1081 HZ
- Recruiting
Investigational Site Number : 5540001
Christchurch, 8011
- Recruiting
Investigational Site Number : 5540003
Lower Hutt, 5010
- Recruiting
Investigational Site Number : 5280001
Nijmegen, 6525GA
- Recruiting
Investigational Site Number : 5540002
Tauranga, 3112
- Recruiting
Investigational Site Number : 5280003
Tilburg, 5022 GC
- Recruiting
Investigational Site Number : 5540005
Wellington, 6021
Colombia6 sites, 6 recruiting
- Recruiting
Investigational Site Number : 1700001
Armenia, Quindío Department, 630004
- Recruiting
Investigational Site Number : 1700003
Barranquilla, Atlántico, 80020
- Recruiting
Investigational Site Number : 1700004
Floridablanca, Santander Department, 681004
- Recruiting
Investigational Site Number : 1700005
Medellín, Antioquia, 50012
- Recruiting
Investigational Site Number : 1700006
Medellín, Antioquia, 50015
- Recruiting
Investigational Site Number : 1700002
Medellín, Antioquia, 50034
Czechia6 sites, 6 recruiting
- Recruiting
Investigational Site Number : 2030001
Brno, 602 00
- Recruiting
Investigational Site Number : 2030008
Brno, 625 00
- Recruiting
Investigational Site Number : 2030003
Brno, Brno
- Recruiting
Investigational Site Number : 2030011
Hradec Králové, 500 12
- Recruiting
Investigational Site Number : 2030013
Prague, 150 00
- Recruiting
Investigational Site Number : 2030006
Prague, 190 00
Italy6 sites, 6 recruiting
- Recruiting
Investigational Site Number : 3800007
Legnano, 20025
- Recruiting
Investigational Site Number : 3800002
Milan, 20132
- Recruiting
Investigational Site Number : 3800009
Rome, 152
- Recruiting
Investigational Site Number : 3800003
Rozzano, 20089
- Recruiting
Investigational Site Number : 3800006
San Donato Milanese, 20097
- Recruiting
Investigational Site Number : 3800005
Turin, 10128
Serbia6 sites, 6 recruiting
- Recruiting
Investigational Site Number : 6880001
Belgrade, 11 000
- Recruiting
Investigational Site Number : 6880002
Belgrade, 11 080
- Recruiting
Investigational Site Number : 6880006
Belgrade, 11000
- Recruiting
Investigational Site Number : 6880007
Belgrade, 11000
- Recruiting
Investigational Site Number : 6880003
Belgrade, 11080
- Recruiting
Investigational Site Number : 6880004
Niš, 18 000
South Africa6 sites, 6 recruiting
- Recruiting
Investigational Site Number : 7100002
Cape Town, 7405
- Recruiting
Investigational Site Number : 7100005
Claremont, 7708
- Recruiting
Investigational Site Number : 7100004
Durban, 3610
- Recruiting
Investigational Site Number : 7100003
East London, 5219
- Recruiting
Investigational Site Number : 7100001
Kempton Park, 1619
- Recruiting
Investigational Site Number : 7100006
KwaZulu-Natal, 4449
United Kingdom6 sites, 6 recruiting
- Recruiting
Investigational Site Number : 8260005
Cambridge, CB2 0QQ
- Recruiting
Investigational Site Number : 8260008
Cottingham, Hull, HU16 5JQ
- Recruiting
Investigational Site Number : 8260007
London, NW3 2QG
- Recruiting
Investigational Site Number : 8260001
London, SE1 9RT
- Recruiting
Investigational Site Number : 8260004
Norwich, NR4 7UY
- Recruiting
Investigational Site Number : 8260003
Rochdale, BL9 7TD
Hungary5 sites, 5 recruiting
- Recruiting
Investigational Site Number : 3480004
Budapest, 1066
- Recruiting
Investigational Site Number : 3480002
Budapest, H-1036
- Recruiting
Investigational Site Number : 3480005
Eger, H-3300
- Recruiting
Investigational Site Number : 3480003
Tatabánya, H-2800
- Recruiting
Investigational Site Number : 3480001
Veszprém, 8200
Belgium4 sites, 4 recruiting
- Recruiting
Investigational Site Number : 0560001
Genk, 3600
- Recruiting
Investigational Site Number : 0560004
Liège, 4000
- Recruiting
Investigational Site Number : 0560002
Sint-Niklaas, B-9100
- Recruiting
Investigational Site Number : 0560003
Yvoir, 5530
Chile4 sites, 4 recruiting
- Recruiting
Investigational Site Number : 1520004
Santiago, 7550000
- Recruiting
Investigational Site Number : 1520003
Santiago, 7770086
- Recruiting
Investigational Site Number : 1520002
Santiago, 8320000
- Recruiting
Investigational Site Number : 1520001
Viña del Mar, 2540488
Moldova4 sites, 4 recruiting
- Recruiting
Investigational Site Number : 4980001
Chisinau, MD-2025
- Recruiting
Investigational Site Number : 4980002
Chisinau, MD-2025
- Recruiting
Investigational Site Number : 4980003
Chisinau, MD-2025
- Recruiting
Investigational Site Number : 4980004
Chisinau, MD-2068
Slovakia4 sites, 4 recruiting
- Recruiting
Investigational Site Number : 7030001
Bratislava, 811 09
- Recruiting
Investigational Site Number : 7030003
Košice, 040 13
- Recruiting
Investigational Site Number : 7030002
Prešov, 080 01
- Recruiting
Investigational Site Number : 7030004
Prešov, 080 01
Spain4 sites, 4 recruiting
- Recruiting
Investigational Site Number : 7240005
Gijón, 33394
- Recruiting
Investigational Site Number : 7240002
Huelva, 21005
- Recruiting
Investigational Site Number : 7240004
Madrid, 28041
- Recruiting
Investigational Site Number : 7240006
Ourense, Galicia, 32005
Greece3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 3000002
Athens, 11527
- Recruiting
Investigational Site Number : 3000001
Heraklion, Crete, 715 00
- Recruiting
Investigational Site Number : 3000003
Larissa, Thessaly, 41110
Mexico3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 4840001
Jalisco, 45640
- Recruiting
Investigational Site Number : 4840006
Monterrey, Nuevo León, 64000
- Recruiting
Investigational Site Number : 4840004
Veracruz, 91910
Lithuania2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 4400001
Kaunas, LT-50161
- Recruiting
Investigational Site Number : 4400002
Panevezys, 35144
Norway2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 5780001
Lorenskog, 1478
- Recruiting
Investigational Site Number : 5780002
Tromsø, 9038
Puerto Rico2 sites, 2 recruiting
- Recruiting
Puerto Rico Health and Wellness Institute-Site Number: 8400104
Dorado, 646
- Recruiting
Wellness Clinical Research - Vega Baja-Site Number: 8400099
Vega Baja, 693
Switzerland2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 7560002
Basel, CH-4058
- 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 Crohn's Disease
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include:
The study duration may be up to 35 weeks with:
Read more
- Up to 5-week 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).
- 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study.
The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.
- Conditions
- Crohn's Disease
- Being tested
- Duvakitug, Placebo
- Medical subject headings
- Crohn Disease
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:Injection solution Route of administration:SC injection
PlaceboDrug
Pharmaceutical form:Injection solution 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.
Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving clinical remission per Crohn's Disease Activity Index (CDAI) at Week 12
Clinical Remission by CDAI: CDAI score <150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease.
Measured: Week 12
Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving endoscopic response (Simple Endoscopic Score for Crohn's Disease [SES-CD]) at Week 12
Endoscopic Response is defined as decrease in SES-CD ≥50% from baseline (or a decrease of at least 2 points for participants with a baseline score of 4 or more, and isolated ileal disease) based on central reading. The SES-CD is a standardized method for evaluating disease activity. The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores represent more severe disease.
Measured: Week 12
Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving clinical remission per 2-item patient-reported outcome (PRO-2) at Week 12
Clinical Remission per PRO-2: average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline.
Measured: Week 12
Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving endoscopic response (SES-CD) at Week 12
Endoscopic Response is defined as decrease in SES-CD ≥50% from baseline (or a decrease of at least 2 points for participants with a baseline score of 4 or more, and isolated ileal disease) based on central reading. The SES-CD is a standardized method for evaluating disease activity. The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores represent more severe disease.
Measured: Week 12
Secondary outcomes (17)
Sub-Study 2: Proportion of participants achieving CDAI clinical response at Week 12
CDAI clinical response is defined as decrease in CDAI score of 100 points or more from baseline.
Measured: Week 12
Sub-study 2: Proportion of participants achieving CDAI clinical response and endoscopic response (SES-CD) at Week 12
CDAI clinical response is defined as decrease in CDAI score of 100 points or more from baseline. Endoscopic Response by SES-CD was defined as a decrease in SES-CD ≥50% from baseline (or a decrease of at least 2 points for participants with a baseline score of 4 or more, and isolated ileal disease) based on central reading.
Measured: Week 12
Sub-study 2: Proportion of participants achieving endoscopic SES-CD remission at Week 12
Endoscopic Remission by SES-CD is defined as SES-DC ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD sub score >1 point from baseline
Measured: Week 12
Sub-study 2: US/FDA: Proportion of participants achieving clinical remission per PRO-2 at Week 12
Clinical Remission per PRO-2: average daily SF ≤3 and not worse than the Baseline, and average daily AP ≤1 and not worse than the Baseline.
Measured: Week 12
Sub-study 2: EU/EMA: Proportion of participants achievingclinical remission per CDAI at Week 12
Clinical Remission by CDAI: CDAI score <150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease.
Measured: Week 12
Sub-study 2: Proportion of participants achieving ulcer-free endoscopy (in the subset of participants with ulcers at baseline) at Week 12
Ulcer-free endoscopy: SES-CD ulcerated surface sub-score of 0 in participants with SES-CD ulcerated surface sub-score ≥1 at Baseline, as scored by a central reader.
Measured: Week 12
Sub-study 2: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 7a T-score at Week 12
The PROMIS Fatigue Short Form 7a uses a 5-point Likert scale for each of its 7 items, resulting in a raw score range of 7 to 35. This raw score is then converted into a T-score, with a mean of 50 and a standard deviation of 10, based on US national norms. Higher T-scores indicate greater fatigue.
Measured: Baseline, Week 12
Sub-study 2: Proportion of participants achieving CDAI clinicalresponse at Week 4
CDAI clinical response is defined as decrease in CDAI score of 100 points or more from baseline.
Measured: Week 4
Sub-study 2: US/FDA: Proportion of participants achievingcorticosteroid free remission (in the subset ofparticipants with corticosteroids at baseline) perCDAI at Week 12
Corticosteroid free remission per CDAI: proportion of participants who discontinue corticosteroid use for CD and achieve clinical remission per CDAI (CDAI score <150) at Week 12, in participants taking corticosteroids for CD at Baseline.
Measured: Week 12
Sub-study 2: EU/EMA: Proportion of participants achievingcorticosteroid free remission per PRO-2 (in thesubset of participants with corticosteroids atbaseline) at Week 12
Corticosteroid free remission by PRO-2: proportion of participants who discontinue corticosteroid use for CD and achieve clinical remission per PRO-2 (average daily SF ≤3 and not worse than the baseline, and average daily AP ≤1 and not worse than the baseline) at Week 12, in participants taking corticosteroids for CD at Baseline.
Measured: Week 12
Sub-study 2: Proportion of participants achieving CDAI clinical remission and endoscopic remission (SES-CD) at Week 12
Clinical Remission by CDAI: CDAI score <150. Endoscopic Remission: SES-CD ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD sub score >1 point from baseline.
Measured: Week 12
Sub-study 2: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 12
IBDQ instrument consist of 32 items exploring 4 dimensions: "bowel symptoms" (10 items), "systemic symptoms" (5 items), "emotional function" (12 items) and "social function" (5 items). The total IBDQ total score ranges from 32 to 224 with higher score indicating better quality of life.
Measured: Baseline, Week 12
Sub-study 2: Proportion of participants with no bowel urgency byNumeric Rating Scale (NRS) at Week 12
The NRS for bowel urgency is a well-defined and reliable instrument to evaluate treatment benefits in participants with CD. The NRS for bowel urgency measures 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, from 0 (no urgency) to 10 (worst possible urgency).
Measured: Week 12
Sub-study 2: Proportion of participants with CD-related hospitalizations by Week 12
Measured: Baseline through Week 12
Sub-study 2: Number of participants with any Treatment Emergent Adverse Events (TEAEs), TEAE of special interest (TEAESIs), TE serious adverse event (TESAEs), and TEAEs leading to permanent study intervention discontinuation
Measured: Baseline through 45 days after the last dose
Sub-study 2: Serum concentrations of duvakitug
Measured: Baseline to Week 12
Sub-study 2: Incidence of treatment-emergent Anti-drug Antibodies (ADA) against duvakitug
Measured: Baseline to 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 start1 Oct 2025
- Primary completion14 May 2029 (estimated)
- Study completion14 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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
- NCT07184931
- Sponsor's protocol ID
- EFC18326
- Other IDs
- 2025-521036-11, U1111-1314-5319, 2025
- Acronym
- STARSCAPE-1
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2025
- Last updated
- 21 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