An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Sponsor: Sanofi • ClinicalTrials.gov ID: NCT07184931
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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: * 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.
Interventions
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Duvakitug
(Drug)
Pharmaceutical form:Injection solution Route of administration:SC injection
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Placebo
(Drug)
Pharmaceutical form:Injection solution Route of administration:SC injection
Eligibility criteria
Conditions
Locations
- Onyx Clinical Research - Site Number:8400021 — Peoria, Arizona, United States
- One of a Kind Clinical Research Center AZ, LLC-Site Number: 8400061 — Scottsdale, Arizona, United States
- Scottsdale Clinical Trials-Site Number: 8400145 — Scottsdale, Arizona, United States
- Del Sol Research Management, LLC-Site Number: 8400012 — Tucson, Arizona, United States
- Preferred Research Partners-Site Number: 8400018 — Little Rock, Arkansas, United States
- Alliance Research Institute-Site Number: 8400008 — Canoga Park, California, United States
- Southern California GI & Liver Centers-Site Number: 8400062 — Coronado, California, United States
- Gastroenterology and Liver Institute - Escondido-Site Number: 8400146 — Escondido, California, United States
- GMC Clinical Research, LLC-Site Number: 8400113 — Folsom, California, United States
- Om Research, LLC - Lancaster-Site Number: 8400148 — Lancaster, California, United States
- TLC Clinical Research Inc.-Site Number: 8400030 — Los Angeles, California, United States
- GastroIntestinal Bioscience - Los Angeles-Site Number: 8400019 — Los Angeles, California, United States
- United Medical Doctors CA-Site Number: 8400044 — Murrieta, California, United States
- Om Research, LLC - Oxnard-Site Number: 8400150 — Oxnard, California, United States
- Prospective Research Innovations Inc.-Site Number: 8400017 — Rancho Cucamonga, California, United States
- UC Davis Health System-Site Number: 8400071 — Sacramento, California, United States
- Clinical Applications Laboratories Inc-Site Number: 8400056 — San Diego, California, United States
- Medical Associates Research Group-Site Number:8400063 — San Diego, California, United States
- Valiance Clinical Research - Tarzana-Site Number: 8400023 — Tarzana, California, United States
- Clinical Trials Management Services-Site Number: 8400047 — Thousand Oaks, California, United States
- Amicis Research Center - Valencia-Site Number: 8400064 — Valencia, California, United States
- Om Research, LLC - Victorville-Site Number: 8400022 — Victorville, California, United States
- UCHealth Digestive Health Center - Anschutz Medical Campus-Site Number: 8400085 — Aurora, Colorado, United States
- Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039 — Colorado Springs, Colorado, United States
- Gastroenterology of the Rockies - Denver-Site Number: 8400122 — Denver, Colorado, United States
- Yale University Digestive Disease-Site Number: 8400108 — New Haven, Connecticut, United States
- Novum Research, LLC-Site Number: 8400003 — Clermont, Florida, United States
- Sarkis Clinical Trials - Gainesville-Site Number: 8400048 — Gainesville, Florida, United States
- Clinical Research of Osceola-Site Number: 8400013 — Kissimmee, Florida, United States
- Columbus Clinical Services LLc-Site Number: 8400038 — Miami, Florida, United States
- Regis Clinical Research, LLC-Site Number: 8400041 — Miami, Florida, United States
- Sylvester Comprehensive Cancer Center - A University of Miami Hospital and Clinics Facility - Miami-Site Number: 8400111 — Miami, Florida, United States
- Medical Professional Clinical Research Center-Site Number: 8400119 — Miami, Florida, United States
- Bioresearch Partner-Kendale Lakes-Site Number: 8400053 — Miami, Florida, United States
- Paradisus Med Research-Site Number: 8400036 — Miami, Florida, United States
- Correa Research Center-Site Number: 8400010 — Miami, Florida, United States
- AdventHealth Orlando-Site Number: 8400070 — Orlando, Florida, United States
- Orlando Health, Inc.-Site Number: 8400084 — Orlando, Florida, United States
- Tropical Clinical Trials-Site Number: 8400082 — Palmetto Bay, Florida, United States
- Precision Clinical Research - Sunrise-Site Number: 8400059 — Sunrise, Florida, United States
- NMC Research LLC-Site Number: 8400033 — Tampa, Florida, United States
- Atlanta Gastroenterology Associates-Site Number: 8400109 — Atlanta, Georgia, United States
- M3 Wake Research - Atlanta-Site Number: 8400028 — Sandy Springs, Georgia, United States
- EBGS Clinical Research Center, LLC-Site Number: 8400037 — Snellville, Georgia, United States
- Atlanta Gastroenterology Specialists-Site Number: 8400149 — Suwanee, Georgia, United States
- Grand Teton Research Group, PLLC-Site Number: 8400127 — Idaho Falls, Idaho, United States
- Rush University Medical Center-Site Number: 8400015 — Chicago, Illinois, United States
- Midwest Digestive Health and Nutrition-Site Number: 8400136 — Des Plaines, Illinois, United States
- GI Alliance - Glenview-Site Number: 8400068 — Glenview, Illinois, United States
- GI Alliance - Gurnee-Site Number: 8400049 — Gurnee, Illinois, United States
- Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100 — New Albany, Indiana, United States
- Heartland Medical Research, Inc.-Site Number: 8400134 — Clive, Iowa, United States
- Digestive Health Research Center-Site Number: 8400096 — Waterloo, Iowa, United States
- University of Kansas Medical Center-Site Number: 8400110 — Kansas City, Kansas, United States
- University of Kentucky Hospital/UK Albert B. Chandler Hospital-Site Number: 8400058 — Lexington, Kentucky, United States
- GI Alliance - Baton Rouge-Site Number: 8400129 — Baton Rouge, Louisiana, United States
- Tandem Intermediate, LLC - Houma-Site Number: 8400034 — Houma, Louisiana, United States
- Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128 — Mandeville, Louisiana, United States
- Tandem Clinical Research - Marrero-Site Number: 8400002 — Marrero, Louisiana, United States
- GI Alliance - Metairie-Site Number: 8400124 — Metairie, Louisiana, United States
- Delta Research Partners-Site Number: 8400087 — Monroe, Louisiana, United States
- Care Access - New Iberia-Site Number: 8400031 — New Iberia, Louisiana, United States
- Mercy Medical Center, Baltimore-Site Number: 8400117 — Baltimore, Maryland, United States
- Mid-Atlantic GI Research, LLC-Site Number: 8400106 — Laurel, Maryland, United States
- Tufts Medical Center-Site Number: 8400126 — Boston, Massachusetts, United States
- UMass Memorial Medical Center-Site Number: 8400121 — Worcester, Massachusetts, United States
- Henry Ford Medical Center - Columbus-Site Number: 8400118 — Novi, Michigan, United States
- Gastroenterology Associates of Western Michigan-Site Number: 8400060 — Wyoming, Michigan, United States
- Allied Health Clinical Research Organization, LLC - Jackson-Site Number:8400007 — Jackson, Mississippi, United States
- BVL Clinical Research-Site Number: 8400005 — Liberty, Missouri, United States
- Washington University School of Medicine-Site Number: 8400075 — St Louis, Missouri, United States
- Gateway Gastroenterology-Site Number: 8400097 — St Louis, Missouri, United States
- Las Vegas Clinical Trials-Site Number: 8400079 — Las Vegas, Nevada, United States
- Sanmora Bespoke Clinical Research Solutions LLC-Site Number: 8400123 — East Orange, New Jersey, United States
- Allied Health Clinical Research Organization, LLC - Freehold-Site Number: 8400014 — Freehold, New Jersey, United States
- Atlantic Health System, Morristown Medical Center-Site Number: 8400137 — Morristown, New Jersey, United States
- Tandem-Allied Clinical Research - Somers Point-Site Number: 8400050 — Somers Point, New Jersey, United States
- Premier Health Research, LLC-Site Number: 8400114 — Sparta, New Jersey, United States
- MedTraits NY-Site Number: 8400045 — Maspeth, New York, United States
- Manhattan Clinical Research, LLC-Site Number: 8400069 — New York, New York, United States
- NYU Langone Health-Site Number: 8400091 — New York, New York, United States
- Columbia University Medical Center-Site Number: 8400138 — New York, New York, United States
- Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040 — New York, New York, United States
- New York Gastroenterology Associates-Site Number: 8400009 — New York, New York, United States
- Montefiore Medical Center - Bronx-Site Number: 8400142 — The Bronx, New York, United States
- UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074 — Chapel Hill, North Carolina, United States
- OnSite Clinical Solutions-Site Number: 8400051 — Charlotte, North Carolina, United States
- Duke University Medical Center-Site Number: 8400093 — Durham, North Carolina, United States
- Cross Creek Medical Clinic-Site Number: 8400057 — Fayetteville, North Carolina, United States
- Monroe Biomedical Research-Site Number: 8400046 — Monroe, North Carolina, United States
- ClinTrial Research, LLC-Site Number: 8400043 — Raleigh, North Carolina, United States
- Plains Clinical Research Center-Site Number: 8400078 — Fargo, North Dakota, United States
- Gastroenterology & Hepatology Specialists, Inc.-Site nUmber: 8400139 — Canton, Ohio, United States
- University Hospitals Cleveland Medical Center-Site Number: 8400073 — Cleveland, Ohio, United States
- Ohio Gastroenterology Group Inc.-8400006 — Columbus, Ohio, United States
- OSU Wexner Medical Center-Site Number: 8400077 — Columbus, Ohio, United States
- DSI Research Northridge - Dayton-Site Number: 8400115 — Dayton, Ohio, United States
- DSI Research - Springboro-Site Number: 8400105 — Springboro, Ohio, United States
- University of Toledo Medical Center-Site Number: 8400042 — Toledo, Ohio, United States
- North Shore Gastroenterology Research-Site Number: 8400130 — Westlake, Ohio, United States
- Central Sooner Research-Site Number: 8400094 — Norman, Oklahoma, United States
- Oregon Health & Science University-Site Number: 8400131 — Portland, Oregon, United States
- Penn State Milton S. Hershey Medical Center-Site Number: 8400066 — Hershey, Pennsylvania, United States
- University of Pennsylvania School of Medicine-Site Number: 8400072 — Philadelphia, Pennsylvania, United States
- The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107 — Pittsburgh, Pennsylvania, United States
- University Gastroenterology-Site Number: 8400103 — Providence, Rhode Island, United States
- Johns Hopkins University Gastroenterology and Hepatology-Site Number: 8400116 — Columbia, South Carolina, United States
- Biocentric Health Research Center-Site Number: 8400089 — Columbia, South Carolina, United States
- Gastro One - Cordova-Site Number: 8400158 — Cordova, Tennessee, United States
- Tri-Cities Gastroenterology-Site Number: 8400076 — Kingsport, Tennessee, United States
- Inquest Clinical Research-Site Number: 8400144 — Baytown, Texas, United States
- The University of Texas Southwestern Medical Center-Site Number: 8400098 — Dallas, Texas, United States
- Valley Institute of Research-Site Number: 8400004 — Harlingen, Texas, United States
- One of a Kind Clinical Research Center TX, LLC-Site Number; 8400125 — Kingwood, Texas, United States
- Innovare Research Group-Site number: 8400067 — Lake Jackson, Texas, United States
- GI Alliance - Lubbock-Site Number: 8400092 — Lubbock, Texas, United States
- SMS Clinical Research-Site Number: 8400035 — Mesquite, Texas, United States
- Gastroenterology Research of San Antonio LLC-Site Number: 8400054 — San Antonio, Texas, United States
- Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Corporate Office-Site Number: 8400101 — Southlake, Texas, United States
- Texas Gastro Consultants-Site Number: 8400029 — Tomball, Texas, United States
- Tyler Research Institute, LLC-Site Number: 8400095 — Tyler, Texas, United States
- Velocity Clinical Research, Salt Lake City-Site Number: 8400147 — West Jordan, Utah, United States
- Blue Ridge Medical Research-Site Number: 8400020 — Lynchburg, Virginia, United States
- Clinical Research Partners-Site Number: 8400080 — Richmond, Virginia, United States
- GI Alliance - Bellevue-Site Number: 8400143 — Bellevue, Washington, United States
- The Vancouver Clinic Inc. P.S.-Site Number: 8400090 — Vancouver, Washington, United States
- Froedtert Hospital and the Medical College of Wisconsin-Site Number: 8400081 — Milwaukee, Wisconsin, United States
- Investigational Site Number : 0320002 — La Plata, Buenos Aires, Argentina
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- Investigational Site Number : 0560001 — Genk, Belgium
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- Investigational Site Number : 2500004 — La Tronche, France
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- Investigational Site Number : 2500006 — Vandœuvre-lès-Nancy, France
- Investigational Site Number : 2680007 — Kutaisi, Georgia
- Investigational Site Number : 2680006 — Tbilisi, Georgia
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- Investigational Site Number : 2760009 — Tübingen, Baden-Wurttemberg, Germany
- Investigational Site Number : 2760005 — Ulm, Baden-Wurttemberg, Germany
- Investigational Site Number : 2760023 — Würzburg, Bavaria, Germany
- Investigational Site Number : 2760013 — Remscheid, North Rhine-Westphalia, Germany
- Investigational Site Number : 2760014 — Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
- Investigational Site Number : 2760008 — Dresden, Saxony, Germany
- Investigational Site Number : 2760015 — Leipzig, Saxony, Germany
- Investigational Site Number : 2760020 — Leipzig, Saxony, Germany
- Investigational Site Number : 2760021 — Halle, Saxony-Anhalt, Germany
- Investigational Site Number : 2760016 — Jerichow, Saxony-Anhalt, Germany
- Investigational Site Number : 2760001 — Kiel, Schleswig-Holstein, Germany
- Investigational Site Number : 2760017 — Berlin, Germany
- Investigational Site Number : 2760006 — Berlin, Germany
- Investigational Site Number : 2760003 — Berlin, Germany
- Investigational Site Number : 2760019 — Dachau, Germany
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- Investigational Site Number : 2760010 — Minden, Germany
- Investigational Site Number : 3000001 — Heraklion, Crete, Greece
- Investigational Site Number : 3000003 — Larissa, Thessaly, Greece
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- Investigational Site Number : 3480004 — Budapest, Hungary
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- Investigational Site Number : 3480005 — Eger, Hungary
- Investigational Site Number : 3480003 — Tatabánya, Hungary
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- Investigational Site Number : 3760004 — Afula, Israel
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- Investigational Site Number : 3760007 — Petah Tikva, Israel
- Investigational Site Number : 3760002 — Tel Aviv, Israel
- Investigational Site Number : 3800007 — Legnano, Italy
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- Investigational Site Number : 3800003 — Rozzano, Italy
- Investigational Site Number : 3800006 — San Donato Milanese, Italy
- Investigational Site Number : 3800005 — Turin, Italy
- Investigational Site Number : 3920046 — Shizuoka, Hamamatsu, Japan
- Investigational Site Number : 3920005 — Asahikawa, Japan
- Investigational Site Number : 3920012 — Bunkyō City, Japan
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- Investigational Site Number : 3920045 — Fukuoka, Japan
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- Investigational Site Number : 3920030 — Kamakura, Japan
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- Investigational Site Number : 3920054 — Kitakyushu, Japan
- Investigational Site Number : 3920019 — Kobe, Japan
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- Investigational Site Number : 6160012 — Wadowice, Poland
- Investigational Site Number : 6160005 — Warsaw, Poland
- Investigational Site Number : 6160031 — Warsaw, Poland
- Investigational Site Number : 6160009 — Warsaw, Poland
- Investigational Site Number : 6160003 — Warsaw, Poland
- Investigational Site Number : 6160008 — Warsaw, Poland
- Investigational Site Number : 6160006 — Wroclaw, Poland
- Investigational Site Number : 6160028 — Wroclaw, Poland
- Investigational Site Number : 6160017 — Wroclaw, Poland
- Puerto Rico Health and Wellness Institute-Site Number: 8400104 — Dorado, Puerto Rico
- Wellness Clinical Research - Vega Baja-Site Number: 8400099 — Vega Baja, Puerto Rico
- Investigational Site Number : 6880001 — Belgrade, Serbia
- Investigational Site Number : 6880002 — Belgrade, Serbia
- Investigational Site Number : 6880006 — Belgrade, Serbia
- Investigational Site Number : 6880007 — Belgrade, Serbia
- Investigational Site Number : 6880003 — Belgrade, Serbia
- Investigational Site Number : 6880004 — Niš, Serbia
- Investigational Site Number : 7030001 — Bratislava, Slovakia
- Investigational Site Number : 7030003 — Košice, Slovakia
- Investigational Site Number : 7030002 — Prešov, Slovakia
- Investigational Site Number : 7030004 — Prešov, Slovakia
- Investigational Site Number : 7100002 — Cape Town, South Africa
- Investigational Site Number : 7100005 — Claremont, South Africa
- Investigational Site Number : 7100004 — Durban, South Africa
- Investigational Site Number : 7100003 — East London, South Africa
- Investigational Site Number : 7100001 — Kempton Park, South Africa
- Investigational Site Number : 7100006 — KwaZulu-Natal, South Africa
- Investigational Site Number : 4100010 — Ansan-si, South Korea
- Investigational Site Number : 4100008 — Busan, South Korea
- Investigational Site Number : 4100009 — Busan, South Korea
- Investigational Site Number : 4100004 — Daegu, South Korea
- Investigational Site Number : 4100003 — Daejeon, South Korea
- Investigational Site Number : 4100007 — Gwangju, South Korea
- Investigational Site Number : 4100006 — Seoul, South Korea
- Investigational Site Number : 4100001 — Seoul, South Korea
- Investigational Site Number : 4100002 — Seoul, South Korea
- Investigational Site Number : 4100005 — Suwon, South Korea
- Investigational Site Number : 7240006 — Ourense, Galicia, Spain
- Investigational Site Number : 7240005 — Gijón, Spain
- Investigational Site Number : 7240002 — Huelva, Spain
- Investigational Site Number : 7240004 — Madrid, Spain
- Investigational Site Number : 7560002 — Basel, Switzerland
- Investigational Site Number : 7560001 — Bern, Switzerland
- Investigational Site Number : 1580005 — Changhua County, Taiwan
- Investigational Site Number : 1580003 — Chiayi City, Taiwan
- Investigational Site Number : 1580010 — Kaohsiung City, Taiwan
- Investigational Site Number : 1580006 — Kaohsiung City, Taiwan
- Investigational Site Number : 1580009 — New Taipei City, Taiwan
- Investigational Site Number : 1580008 — Tainan, Taiwan
- Investigational Site Number : 1580007 — Tainan, Taiwan
- Investigational Site Number : 1580002 — Taipei, Taiwan
- Investigational Site Number : 1580001 — Taoyuan City, Taiwan
- Investigational Site Number : 8040003 — Chernivtsi, Ukraine
- Investigational Site Number : 8040001 — Kyiv, Ukraine
- Investigational Site Number : 8040013 — Kyiv, Ukraine
- Investigational Site Number : 8040002 — Kyiv, Ukraine
- Investigational Site Number : 8040004 — Lviv, Ukraine
- Investigational Site Number : 8040011 — Lviv, Ukraine
- Investigational Site Number : 8040005 — Lviv, Ukraine
- Investigational Site Number : 8040006 — Uzhhorod, Ukraine
- Investigational Site Number : 8040010 — Vinnytsia, Ukraine
- Investigational Site Number : 8040009 — Vinnytsia, Ukraine
- Investigational Site Number : 8040008 — Vinnytsia, Ukraine
- Investigational Site Number : 8260008 — Cottingham, Hull, United Kingdom
- Investigational Site Number : 8260005 — Cambridge, United Kingdom
- Investigational Site Number : 8260007 — London, United Kingdom
- Investigational Site Number : 8260001 — London, United Kingdom
- Investigational Site Number : 8260004 — Norwich, United Kingdom
- Investigational Site Number : 8260003 — Rochdale, United Kingdom
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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