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RECRUITINGPhase 3INTERVENTIONAL

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

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.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Duvakitug

Pharmaceutical form:Solution for Injection-Route of administration:SC injection

DRUG

Placebo

Pharmaceutical form:Solution for injection-Route of administration:SC injection

Locations (20)

Onyx Clinical Research - Site Number: 8400021
Peoria, Arizona, United States
One of a Kind Clinical Research Center LLC - Site Number: 8400061
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
FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027
Arcadia, California, 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
GMC Clinical Research, LLC - Site Number: 8400113
Folsom, California, United States
TLC Clinical Research Inc. - Site Number: 8400030
Los Angeles, California, United States
United Medical Doctors CA - Site Number: 8400044
Murrieta, California, United States
Medical Associates Research Group - Site Number: 8400063
San Diego, California, United States
Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025
Santa Maria, 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
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
Novum Research, LLC - Site Number: 8400003
Clermont, Florida, United States
Precision Clinical Research-Site Number: 8400059
Coral Springs, Florida, United States