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 (74) 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
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
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
Florida
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
Regis Clinical Research, LLC - Site Number: 8400041
RECRUITING
Miami
NMC Research LLC - Site Number: 8400033
RECRUITING
Tampa
Georgia
M3 Wake Research - Atlanta - Site Number: 8400028
RECRUITING
Sandy Springs
EBGS Clinical Research Center, LLC - Site Number: 8400037
RECRUITING
Snellville
Illinois
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
GI Alliance - Metairie - Site Number: 8400124
RECRUITING
Metairie
Delta Research Partners
RECRUITING
Monroe
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
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
Premier Health Research, LLC - Site Number: 8400114
RECRUITING
Sparta
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
Ohio
Ohio Gastroenterology Group Inc. - Site Number: 8400006
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
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
Innovare Research Group - Site Number: 8400067
RECRUITING
Lake Jackson
Texas Digestive Disease Consultants dba GI Alliance - Lubbock - Site Number: 8400092
RECRUITING
Lubbock
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
Japan
Asahikawa City Hospital - Site Number : 3920011
RECRUITING
Asahikawa
Kagoshima IBD Gastroenterology Clinic - Site Number : 3920049
RECRUITING
Kagoshima
Ofuna Chuo Hospital - Site Number : 3920029
RECRUITING
Kamakura
Kokikai Tsujinaka Hospital Kashiwanoha - Site Number : 3920031
RECRUITING
Kashiwa
Aoyama Clinic, Site Number : 3920018
RECRUITING
Kobe
Sapporo Tokushukai Hospital - Site Number : 3920019
RECRUITING
Sapporo
Tokai University Hachioji Hospital - Site Number : 3920030
RECRUITING
Tokyo
Toyama University Hospital - Site Number : 3920032
RECRUITING
Toyama
Puerto Rico
Wellness Clinical Research - Vega Baja - Site Number: 8400099
RECRUITING
Vega Baja
Serbia
Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine, Department of Gastroenterology and Hepatology -Site Number : 6880002
RECRUITING
Belgrade
Zvezdara University Medical Center, Clinic of Internal Diseases, Clinical Department of Gastroenterology and Hepatology -Site Number : 6880001
RECRUITING
Belgrade
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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