An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Ulcerative Colitis
Спонсор: Sanofi
Налично на:
БГ
Обобщение
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.
Кой може да участва
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Интервенции
Duvakitug
DRUG
Placebo
DRUG
Места на провеждане
191
България (3)
Investigational Site Number : 1000007
Rusa
Investigational Site Number : 1000008
Sofia
Investigational Site Number : 1000001
Sofia
Канада (3)
Charlton Digestive Disease Centre - Site Number : 1240009
Hamilton
Oakville Endoscopy Center Inc. DBA ABP Research Services Corp. - Site Number : 1240010
Oakville
Toronto Immune and Digestive Health Institute Inc. (TIDHI) - Site Number : 1240003
Toronto
Китай (1)
Investigational Site Number : 1560001
Chengdu
Чехия (1)
Investigational Site Number : 2030011
Hradec Králové
Франция (3)
Investigational Site Number : 2500010
Lille
Investigational Site Number : 2500013
Nice
Investigational Site Number : 2500006
Vandœuvre-lès-Nancy
Georgia (7)
Investigational Site Number : 2680007
Kutaisi
Investigational Site Number : 2680006
Tbilisi
Investigational Site Number : 2680008
Tbilisi
Investigational Site Number : 2680005
Tbilisi
Investigational Site Number : 2680003
Tbilisi
LLC The First Medical Center - Site Number : 2680004
Tbilisi
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC - Site Number : 2680002
Tbilisi
Германия (6)
Investigational Site Number : 2760003
Berlin
Investigational Site Number : 2760026
Herne
Investigational Site Number : 2760001
Kiel
Investigational Site Number : 2760015
Leipzig
Investigational Site Number : 2760010
Minden
Investigational Site Number : 2760005
Ulm
Унгария (1)
Investigational Site Number : 3480004
Budapest
Япония (32)
Asahikawa City Hospital - Site Number : 3920011
Asahikawa
Investigational Site Number : 3920005
Asahikawa
The University of Tokyo Hospital - Site Number : 3920059
Bunkyō City
Investigational Site Number : 3920039
Chikushino-shi
Investigational Site Number : 3920021
Chūō
Japanese Red Cross Fukuoka Hospital - Site Number : 3920027
Fukuoka
Kagoshima IBD Gastroenterology Clinic - Site Number : 3920049
Kagoshima
Ofuna Chuo Hospital - Site Number : 3920029
Kamakura
National Hospital Organization Kanazawa Medical Center - Investigational Site Number : 3920010
Kanazawa
Kokikai Tsujinaka Hospital Kashiwanoha - Site Number : 3920031
Kashiwa
Aoyama Clinic, Site Number : 3920018
Kobe
Hattori Clinic - Site Number : 3920051
Kumamoto
Nagaoka Red Cross Hospital - Site Number : 3920041
Nagaoka
Investigational Site Number : 3920008
Okayama
Investigational Site Number : 3920050
Osaka
National Hospital Organization Osaka National Hospital - Investigational Site Number : 3920002
Osaka
Public Institution Panevezys Republican hospital - Site Number : 4400002
Panevezys
Investigational Site Number : 3920014
Saga
Investigational Site Number : 3920023
Sakura
Sapporo Tokushukai Hospital - Site Number : 3920019
Sapporo
Investigational Site Number : 3920056
Sapporo
Sapporo Higashi Tokushukai Hospital - Investigational Site Number : 3920042
Sapporo
Takagi Clinic - Site Number : 3920004
Sendai
National Hospital Organization Sendai Medical Center - Investigational Site Number : 3920003
Sendai
National Center for Global Health and Medicine - Site Number : 3920038
Shinjuku
Iwate Medical University Hospital - Site Number : 3920020
Shiwa-gun
Tokai University Hachioji Hospital - Site Number : 3920030
Tokyo
Toyama University Hospital - Site Number : 3920032
Toyama
Toyama Prefectural Central Hospital - Site Number : 3920037
Toyama
Investigational Site Number : 3920015
Toyohashi
Mie University Hospital - Investigational Site Number : 3920009
Tsu
Investigational Site Number : 3920035
Yokohama
Lithuania (1)
Investigational Site Number : 4400001
Kaunas
Moldova (3)
Investigational Site Number : 4980003
Chisinau
PMSI 'Timofei Mosneaga' Republican Clinical Hospital - Site Number : 4980002
Chisinau
'Sfanta Treime' Municipal Clinical Hospital - Site Number : 4980004
Chisinau
Полша (15)
Investigational Site Number : 6160013
Elblag
Investigational Site Number : 6160014
Katowice
Investigational Site Number : 6160022
Krakow
Investigational Site Number : 6160016
Lodz
Investigational Site Number : 6160018
Poznan
Investigational Site Number : 6160025
Rzeszów
Endoskopia Sp. z o.o. (LLC) - Site Number : 6160004
Sopot
New health-CK, Kieltucki and partners g.p. - Site Number : 6160007
Staszów
Investigational Site Number : 6160002
Szczecin
SONOMED - Site Number : 6160020
Szczecin
Investigational Site Number : 6160012
Wadowice
Investigational Site Number : 6160005
Warsaw
Investigational Site Number : 6160006
Warsaw
Investigational Site Number : 6160031
Warsaw
Investigational Site Number : 6160028
Wrocklaw
Puerto Rico (1)
Wellness Clinical Research - Vega Baja - Site Number: 8400099
Vega Baja
Сърбия (5)
Zvezdara University Medical Center, Clinic of Internal Diseases, Clinical Department of Gastroenterology and Hepatology -Site Number : 6880001
Belgrade
Clinical Hospital Center 'Dr. Dragisa Misovic-Dedinje' - Site Number : 6880007
Belgrade
University Clinical Center of Serbia - Site Number : 6880006
Belgrade
Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine, Department of Gastroenterology and Hepatology -Site Number : 6880002
Belgrade
Investigational Site Number : 6880004
Niš
Словакия (1)
Investigational Site Number : 7030001
Bratislava
South Africa (3)
Investigational Site Number : 7100005
Claremont
Investigational Site Number : 7100004
Durban
Investigational Site Number : 7100001
Kempton Park
Швейцария (1)
Investigational Site Number : 7560001
Bern
Taiwan (2)
Investigational Site Number : 1580003
Chiayi City
National Taiwan University Hospital - Site Number : 1580002
Taipei
Ukraine (11)
Bukovinian State Medical University - Site Number : 8040003
Chernivtsi
Limited Liability Company 'Edelweiss Medics' - Site Number : 8040001
Kyiv
Investigational Site Number : 8040013
Kyiv
Limited Liability Company 'Medbud-Clinic' - Site Number : 8040002
Kyiv
University Hospital of the State Non-Profit Enterprise 'Danylo Halytsky Lviv National Medical University' - Site Number : 8040004
Lviv
State Non-Profit Enterprise 'Danulo Halytsky National Medical University in Lviv' - Site Number : 8040012
Lviv
Limited Liability Company 'PROGASTRO CLINIC' - Site Number : 8040005
Lviv
Public Non-Profit Enterprise 'Andrii Novak Zakarpattia Regional Clinical Hospital' under Zakarpattia Regional Council - Site Number : 8040006
Uzhhorod
Limited Liability Company 'Center of Gastroenterology and Dietology' - Site Number : 8040010
Vinnytsia
National Pirogov Memorial Medical University - Site Number : 8040009
Vinnytsia
National Pirogov Memorial Medical University - Site Number : 8040008
Vinnytsia
САЩ (91)
FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027
Arcadia , California
Atlanta Gastroenterology Associates - Site Number: 8400109
Atlanta , Georgia
GI Alliance - Baton Rouge - Site Number: 8400129
Baton Rouge , Louisiana
Alliance Research Institute - Site Number: 8400008
Canoga Park , California
Gastroenterology & Hepatology Specialists, Inc. - Site Number: 8400139
Canton , Ohio
UNC Hospitals, The University of North Carolina at Chapel Hill - Site Number: 8400074
Chapel Hill , North Carolina
OnSite Clinical Solutions - Site Number: 8400051
Charlotte , North Carolina
Gateway Gastroenterology - Site Number: 8400097
Chesterfield , Missouri
Novum Research, LLC - Site Number: 8400003
Clermont , Florida
Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039
Colorado Springs , Colorado
Ohio Gastroenterology Group Inc. - Site Number: 8400006
Columbus , Ohio
OSU Wexner Medical Center - Site Number: 8400077
Columbus , Ohio
Precision Clinical Research-Site Number: 8400059
Coral Springs , Florida
Southern California GI & Liver Centers - Site Number: 8400062
Coronado , California
DSI Research, LLC - Site Number: 8400115
Dayton , Ohio
Gastroenterology of the Rockies - Denver - Site Number: 8400122
Denver , Colorado
Midwest Digestive Health and Nutrition - Site Number: 8400136
Des Plaines , Illinois
Sanmora Bespoke Clinical Research Solutions LLC - Site Number: 8400123
East Orange , New Jersey
Plains Medical Clinic - Site Number: 8400078
Fargo , North Dakota
Cross Creek Medical Clinic - Site Number: 8400057
Fayetteville , North Carolina
GMC Clinical Research, LLC - Site Number: 8400113
Folsom , California
Allied Health Clinical Research Organization, LLC - Freehold - Site Number: 8400014
Freehold , New Jersey
Sarkis Clinical Trials-Ocala - Site Number: 8400048
Gainesville , Florida
GI Alliance - Glenview - Site Number: 8400068
Glenview , Illinois
Mid-Atlantic GI Research, LLC - Site Number: 8400106
Greenbelt , Maryland
Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee - Site Number: 8400049
Gurnee , Illinois
Valley Institute of Research - Site Number: 8400004
Harlingen , Texas
Tandem Intermediate, LLC - Houma -Site Number: 8400034
Houma , Louisiana
Grand Teton Research Group, PLLC - Site Number: 8400127
Idaho Falls , Idaho
Allied Health Clinical Research Organization, LLC - Jackson - Site Number: 8400007
Jackson , New Jersey
One of a Kind Clinical Research Center LLC - Texas - Site Number: 8400125
Kingwood , Texas
Clinical Research of Osceola - Site Number: 8400013
Kissimmee , Florida
Innovare Research Group - Site Number: 8400067
Lake Jackson , Texas
Las Vegas Clinical Trials - Site Number: 8400079
Las Vegas , Nevada
BVL Clinical Research - Site Number: 8400005
Liberty , Missouri
Preferred Research Partners - Site Number: 8400018
Little Rock , Arkansas
TLC Clinical Research Inc. - Site Number: 8400030
Los Angeles , California
Texas Digestive Disease Consultants dba GI Alliance - Lubbock - Site Number: 8400092
Lubbock , Texas
Blue Ridge Medical Research - Site Number: 8400020
Lynchburg , Virginia
GastroGroup - Site Number: 8400128
Mandeville , Louisiana
Tandem Clinical Research - Marrero - Site Number: 8400002
Marrero , Louisiana
MedTraits NY - Site Number: 8400045
Maspeth , New York
SMS Clinical Research - Site Number: 8400035
Mesquite , Nevada
GI Alliance - Metairie - Site Number: 8400124
Metairie , Louisiana
Columbus Clinical Services LLc - Site Number: 8400038
Miami , Florida
Regis Clinical Research, LLC - Site Number: 8400041
Miami , Florida
Bio Research Partner - Site Number: 8400053
Miami , Florida
Medical Professional Clinical Research Center - Site Number: 8400119
Miami , Florida
Correa Research Center-Site Number: 8400010
Miami , Florida
Monroe Biomedical Research - Site Number: 8400046
Monroe , North Carolina
Delta Research Partners
Monroe , Louisiana
United Medical Doctors CA - Site Number: 8400044
Murrieta , California
Gastroenterology Health Partners, PLLC - Site Number: 8400100
New Albany , Indiana
Care Access - New Iberia - Site Number: 8400031
New Iberia , Louisiana
Manhattan Clinical Research, LLC - Site Number: 8400069
New York , New York
NYU Langone Health - Site Number: 8400091
New York , New York
Weill Cornell Medical College - NewYork-Presbyterian Hospital - Site Number: 8400040
New York , New York
New York Gastroenterology Associates - Site Number: 8400009
New York , New York
Central Sooner Research - Site Number: 8400094
Norman , Oklahoma
Orlando Health, Inc. - Site Number: 8400084
Orlando , Florida
Tropical Clinical Trials - Site Number: 8400082
Palmetto Bay , Florida
Onyx Clinical Research - Site Number: 8400021
Peoria , Arizona
University of Pennsylvania School of Medicine - Site Number: 8400072
Philadelphia , Pennsylvania
The Allegheny Health Network (AHN) Center for Digestive Health - Site Number: 8400107
Pittsburgh , Pennsylvania
University Gastroenterology - GI Alliance - Site Number: 8400103
Providence , Rhode Island
ClinTrial Research, LLC - Site Number: 8400043
Raleigh , North Carolina
Clinical Research Partners - Site Number: 8400080
Richmond , Virginia
Gastroenterology Research of San Antonio LLC - Site Number: 8400054
San Antonio , Texas
Medical Associates Research Group - Site Number: 8400063
San Diego , California
M3 Wake Research - Atlanta - Site Number: 8400028
Sandy Springs , Georgia
Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025
Santa Maria , California
One of a Kind Clinical Research Center LLC - Site Number: 8400061
Scottsdale , Arizona
EBGS Clinical Research Center, LLC - Site Number: 8400037
Snellville , Georgia
Tandem-Allied Clinical Research - Somers Point - Site Number: 840050
Somers Point , New Jersey
Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Site Number: 8400101
Southlake , Texas
Premier Health Research, LLC - Site Number: 8400114
Sparta , New Jersey
DSI Research, LLC - Site Number: 8400105
Springboro , Ohio
NMC Research LLC - Site Number: 8400033
Tampa , Florida
Valiance Clinical Research - Tarzana - Site Number: 8400023
Tarzana , California
Clinical Trials Management Services - Site Number: 8400047
Thousand Oaks , California
Texas Gastro Consultants - Site Number: 8400029
Tomball , Texas
Del Sol Research Management, LLC - Site Number: 8400012
Tucson , Arizona
Tyler Research Institute, LLC - Site Number: 8400095
Tyler , Texas
Amicis Research Center-Valencia -Site Number: 8400064
Valencia , California
The Vancouver Clinic Inc. P.S. - Site Number: 8400090
Vancouver , Washington
Om Research, LLC - Victorville - Site Number: 8400022
Victorville , California
Cedar Valley Digestive Health Center - Site Number: 8400096
Waterloo , Iowa
Biocentric Health Research Partner
West Columbia , South Carolina
North Shore Gastroenterology Research - Site Number: 8400130
Westlake , Ohio
UMass Memorial Medical Center - Site Number: 8400121
Worcester , Massachusetts
Gastroenterology Associates of Western Michigan - Site Number: 8400060
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