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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 Crohn's Disease
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.
Age
16 - 80 years
Sex
ALL
Healthy Volunteers
No
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: 8400018
Little Rock, Arkansas, United States
Kagoshima IBD Gastroenterology Clinic - 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.: 8400030
Los Angeles, California, United States
United Medical Doctors CA-Site Number: 8400044
Murrieta, California, United States
Prospective Research Innovations Inc.: 8400017
Rancho Cucamonga, California, United States
Start Date
October 1, 2025
Primary Completion Date
May 14, 2029
Completion Date
May 14, 2029
Last Updated
March 2, 2026
980
ESTIMATED participants
Duvakitug
DRUG
Placebo
DRUG
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
800-633-1610Contact-US@sanofi.comLead Sponsor
Sanofi
Collaborators
NCT06226883
NCT06918808
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07385131