Hemorrhagic Proctocolitis Clinical Trials

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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.

Status: Recruiting
Location: See all (140) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Arkansas
Preferred Research Partners - Site Number: 8400018
RECRUITING
Little Rock
Arizona
Onyx Clinical Research - Site Number: 8400021
RECRUITING
Peoria
One of a Kind Clinical Research Center LLC - Site Number: 8400061
RECRUITING
Scottsdale
Del Sol Research Management, LLC - Site Number: 8400012
RECRUITING
Tucson
California
FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027
RECRUITING
Arcadia
Alliance Research Institute - Site Number: 8400008
RECRUITING
Canoga Park
Southern California GI & Liver Centers - Site Number: 8400062
RECRUITING
Coronado
GMC Clinical Research, LLC - Site Number: 8400113
RECRUITING
Folsom
TLC Clinical Research Inc. - Site Number: 8400030
RECRUITING
Los Angeles
United Medical Doctors CA - Site Number: 8400044
RECRUITING
Murrieta
Medical Associates Research Group - Site Number: 8400063
RECRUITING
San Diego
Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025
RECRUITING
Santa Maria
Valiance Clinical Research - Tarzana - Site Number: 8400023
RECRUITING
Tarzana
Clinical Trials Management Services - Site Number: 8400047
RECRUITING
Thousand Oaks
Amicis Research Center-Valencia -Site Number: 8400064
RECRUITING
Valencia
Om Research, LLC - Victorville - Site Number: 8400022
RECRUITING
Victorville
Colorado
Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039
RECRUITING
Colorado Springs
Gastroenterology of the Rockies - Denver - Site Number: 8400122
RECRUITING
Denver
Florida
Novum Research, LLC - Site Number: 8400003
RECRUITING
Clermont
Precision Clinical Research-Site Number: 8400059
RECRUITING
Coral Springs
Sarkis Clinical Trials-Ocala - Site Number: 8400048
RECRUITING
Gainesville
Clinical Research of Osceola - Site Number: 8400013
RECRUITING
Kissimmee
Bio Research Partner - Site Number: 8400053
RECRUITING
Miami
Columbus Clinical Services LLc - Site Number: 8400038
RECRUITING
Miami
Correa Research Center-Site Number: 8400010
RECRUITING
Miami
Medical Professional Clinical Research Center - Site Number: 8400119
RECRUITING
Miami
Regis Clinical Research, LLC - Site Number: 8400041
RECRUITING
Miami
Orlando Health, Inc. - Site Number: 8400084
RECRUITING
Orlando
Tropical Clinical Trials - Site Number: 8400082
RECRUITING
Palmetto Bay
NMC Research LLC - Site Number: 8400033
RECRUITING
Tampa
Georgia
Atlanta Gastroenterology Associates - Site Number: 8400109
RECRUITING
Atlanta
M3 Wake Research - Atlanta - Site Number: 8400028
RECRUITING
Sandy Springs
EBGS Clinical Research Center, LLC - Site Number: 8400037
RECRUITING
Snellville
Iowa
Cedar Valley Digestive Health Center - Site Number: 8400096
RECRUITING
Waterloo
Idaho
Grand Teton Research Group, PLLC - Site Number: 8400127
RECRUITING
Idaho Falls
Illinois
Midwest Digestive Health and Nutrition - Site Number: 8400136
RECRUITING
Des Plaines
GI Alliance - Glenview - Site Number: 8400068
RECRUITING
Glenview
Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee - Site Number: 8400049
RECRUITING
Gurnee
Indiana
Gastroenterology Health Partners, PLLC - Site Number: 8400100
RECRUITING
New Albany
Louisiana
GI Alliance - Baton Rouge - Site Number: 8400129
RECRUITING
Baton Rouge
Tandem Intermediate, LLC - Houma -Site Number: 8400034
RECRUITING
Houma
GastroGroup - Site Number: 8400128
RECRUITING
Mandeville
Tandem Clinical Research - Marrero - Site Number: 8400002
RECRUITING
Marrero
GI Alliance - Metairie - Site Number: 8400124
RECRUITING
Metairie
Delta Research Partners
RECRUITING
Monroe
Care Access - New Iberia - Site Number: 8400031
RECRUITING
New Iberia
Massachusetts
UMass Memorial Medical Center - Site Number: 8400121
RECRUITING
Worcester
Maryland
Mid-Atlantic GI Research, LLC - Site Number: 8400106
RECRUITING
Greenbelt
Michigan
Gastroenterology Associates of Western Michigan - Site Number: 8400060
RECRUITING
Wyoming
Missouri
Gateway Gastroenterology - Site Number: 8400097
RECRUITING
Chesterfield
BVL Clinical Research - Site Number: 8400005
RECRUITING
Liberty
North Carolina
UNC Hospitals, The University of North Carolina at Chapel Hill - Site Number: 8400074
RECRUITING
Chapel Hill
OnSite Clinical Solutions - Site Number: 8400051
RECRUITING
Charlotte
Cross Creek Medical Clinic - Site Number: 8400057
RECRUITING
Fayetteville
Monroe Biomedical Research - Site Number: 8400046
RECRUITING
Monroe
ClinTrial Research, LLC - Site Number: 8400043
RECRUITING
Raleigh
North Dakota
Plains Medical Clinic - Site Number: 8400078
RECRUITING
Fargo
New Jersey
Sanmora Bespoke Clinical Research Solutions LLC - Site Number: 8400123
RECRUITING
East Orange
Allied Health Clinical Research Organization, LLC - Freehold - Site Number: 8400014
RECRUITING
Freehold
Allied Health Clinical Research Organization, LLC - Jackson - Site Number: 8400007
RECRUITING
Jackson
Tandem-Allied Clinical Research - Somers Point - Site Number: 840050
RECRUITING
Somers Point
Premier Health Research, LLC - Site Number: 8400114
RECRUITING
Sparta
Nevada
Las Vegas Clinical Trials - Site Number: 8400079
RECRUITING
Las Vegas
SMS Clinical Research - Site Number: 8400035
RECRUITING
Mesquite
New York
MedTraits NY - Site Number: 8400045
RECRUITING
Maspeth
Manhattan Clinical Research, LLC - Site Number: 8400069
RECRUITING
New York
New York Gastroenterology Associates - Site Number: 8400009
RECRUITING
New York
NYU Langone Health - Site Number: 8400091
RECRUITING
New York
Weill Cornell Medical College - NewYork-Presbyterian Hospital - Site Number: 8400040
RECRUITING
New York
Ohio
Gastroenterology & Hepatology Specialists, Inc. - Site Number: 8400139
RECRUITING
Canton
Ohio Gastroenterology Group Inc. - Site Number: 8400006
RECRUITING
Columbus
OSU Wexner Medical Center - Site Number: 8400077
RECRUITING
Columbus
DSI Research, LLC - Site Number: 8400115
RECRUITING
Dayton
DSI Research, LLC - Site Number: 8400105
RECRUITING
Springboro
North Shore Gastroenterology Research - Site Number: 8400130
RECRUITING
Westlake
Oklahoma
Central Sooner Research - Site Number: 8400094
RECRUITING
Norman
Pennsylvania
University of Pennsylvania School of Medicine - Site Number: 8400072
RECRUITING
Philadelphia
Rhode Island
University Gastroenterology - GI Alliance - Site Number: 8400103
RECRUITING
Providence
South Carolina
Biocentric Health Research Partner
RECRUITING
West Columbia
Texas
Valley Institute of Research - Site Number: 8400004
RECRUITING
Harlingen
One of a Kind Clinical Research Center LLC - Texas - Site Number: 8400125
RECRUITING
Kingwood
Innovare Research Group - Site Number: 8400067
RECRUITING
Lake Jackson
Texas Digestive Disease Consultants dba GI Alliance - Lubbock - Site Number: 8400092
RECRUITING
Lubbock
Gastroenterology Research of San Antonio LLC - Site Number: 8400054
RECRUITING
San Antonio
Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Site Number: 8400101
RECRUITING
Southlake
Texas Gastro Consultants - Site Number: 8400029
RECRUITING
Tomball
Tyler Research Institute, LLC - Site Number: 8400095
RECRUITING
Tyler
Virginia
Blue Ridge Medical Research - Site Number: 8400020
RECRUITING
Lynchburg
Clinical Research Partners - Site Number: 8400080
RECRUITING
Richmond
Washington
The Vancouver Clinic Inc. P.S. - Site Number: 8400090
RECRUITING
Vancouver
Other Locations
Canada
Charlton Digestive Disease Centre - Site Number : 1240009
RECRUITING
Hamilton
Oakville Endoscopy Center Inc. DBA ABP Research Services Corp. - Site Number : 1240010
RECRUITING
Oakville
Toronto Immune and Digestive Health Institute Inc. (TIDHI) - Site Number : 1240003
RECRUITING
Toronto
Georgia
LLC The First Medical Center - Site Number : 2680004
RECRUITING
Tbilisi
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC - Site Number : 2680002
RECRUITING
Tbilisi
Japan
Asahikawa City Hospital - Site Number : 3920011
RECRUITING
Asahikawa
The University of Tokyo Hospital - Site Number : 3920059
RECRUITING
Bunkyō City
Japanese Red Cross Fukuoka Hospital - Site Number : 3920027
RECRUITING
Fukuoka
Kagoshima IBD Gastroenterology Clinic - Site Number : 3920049
RECRUITING
Kagoshima
Ofuna Chuo Hospital - Site Number : 3920029
RECRUITING
Kamakura
National Hospital Organization Kanazawa Medical Center - Investigational Site Number : 3920010
RECRUITING
Kanazawa
Kokikai Tsujinaka Hospital Kashiwanoha - Site Number : 3920031
RECRUITING
Kashiwa
Aoyama Clinic, Site Number : 3920018
RECRUITING
Kobe
Hattori Clinic - Site Number : 3920051
RECRUITING
Kumamoto
Nagaoka Red Cross Hospital - Site Number : 3920041
RECRUITING
Nagaoka
National Hospital Organization Osaka National Hospital - Investigational Site Number : 3920002
RECRUITING
Osaka
Public Institution Panevezys Republican hospital - Site Number : 4400002
RECRUITING
Panevezys
Sapporo Higashi Tokushukai Hospital - Investigational Site Number : 3920042
RECRUITING
Sapporo
Sapporo Tokushukai Hospital - Site Number : 3920019
RECRUITING
Sapporo
National Hospital Organization Sendai Medical Center - Investigational Site Number : 3920003
RECRUITING
Sendai
Takagi Clinic - Site Number : 3920004
RECRUITING
Sendai
National Center for Global Health and Medicine - Site Number : 3920038
RECRUITING
Shinjuku
Iwate Medical University Hospital - Site Number : 3920020
RECRUITING
Shiwa-gun
Tokai University Hachioji Hospital - Site Number : 3920030
RECRUITING
Tokyo
Toyama Prefectural Central Hospital - Site Number : 3920037
RECRUITING
Toyama
Toyama University Hospital - Site Number : 3920032
RECRUITING
Toyama
Mie University Hospital - Investigational Site Number : 3920009
RECRUITING
Tsu
Poland
Endoskopia Sp. z o.o. (LLC) - Site Number : 6160004
RECRUITING
Sopot
New health-CK, Kieltucki and partners g.p. - Site Number : 6160007
RECRUITING
Staszów
SONOMED - Site Number : 6160020
RECRUITING
Szczecin
Puerto Rico
Wellness Clinical Research - Vega Baja - Site Number: 8400099
RECRUITING
Vega Baja
Republic of Moldova
'Sfanta Treime' Municipal Clinical Hospital - Site Number : 4980004
RECRUITING
Chisinau
Investigational Site Number : 4980003
RECRUITING
Chisinau
PMSI 'Timofei Mosneaga' Republican Clinical Hospital - Site Number : 4980002
RECRUITING
Chisinau
Serbia
Clinical Hospital Center 'Dr. Dragisa Misovic-Dedinje' - Site Number : 6880007
RECRUITING
Belgrade
Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine, Department of Gastroenterology and Hepatology -Site Number : 6880002
RECRUITING
Belgrade
University Clinical Center of Serbia - Site Number : 6880006
RECRUITING
Belgrade
Zvezdara University Medical Center, Clinic of Internal Diseases, Clinical Department of Gastroenterology and Hepatology -Site Number : 6880001
RECRUITING
Belgrade
Switzerland
Investigational Site Number : 7560001
RECRUITING
Bern
Taiwan
National Taiwan University Hospital - Site Number : 1580002
RECRUITING
Taipei
Ukraine
Bukovinian State Medical University - Site Number : 8040003
RECRUITING
Chernivtsi
Limited Liability Company 'Edelweiss Medics' - Site Number : 8040001
RECRUITING
Kyiv
Limited Liability Company 'Medbud-Clinic' - Site Number : 8040002
RECRUITING
Kyiv
Limited Liability Company 'PROGASTRO CLINIC' - Site Number : 8040005
RECRUITING
Lviv
State Non-Profit Enterprise 'Danulo Halytsky National Medical University in Lviv' - Site Number : 8040012
RECRUITING
Lviv
University Hospital of the State Non-Profit Enterprise 'Danylo Halytsky Lviv National Medical University' - Site Number : 8040004
RECRUITING
Lviv
Public Non-Profit Enterprise 'Andrii Novak Zakarpattia Regional Clinical Hospital' under Zakarpattia Regional Council - Site Number : 8040006
RECRUITING
Uzhhorod
Limited Liability Company 'Center of Gastroenterology and Dietology' - Site Number : 8040010
RECRUITING
Vinnytsia
National Pirogov Memorial Medical University - Site Number : 8040008
RECRUITING
Vinnytsia
National Pirogov Memorial Medical University - Site Number : 8040009
RECRUITING
Vinnytsia
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2025-10-08
Estimated Completion Date: 2028-05-09
Participants
Target number of participants: 980
Treatments
Experimental: Duvakitug - dose 1
Subcutaneous (SC) injection as per protocol
Experimental: Duvakitug - dose 2
SC injection as per protocol
Placebo_comparator: Placebo
SC injection as per protocol
Sponsors
Collaborators: Teva Branded Pharmaceutical Products R&D LLC
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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