An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT07184996
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
980 participants
INTERVENTIONAL
2025-10-08
2028-05-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Duvakitug - dose 1
Subcutaneous (SC) injection as per protocol
Duvakitug
Pharmaceutical form:Solution for Injection-Route of administration:SC injection
Duvakitug - dose 2
SC injection as per protocol
Duvakitug
Pharmaceutical form:Solution for Injection-Route of administration:SC injection
Placebo
SC injection as per protocol
Placebo
Pharmaceutical form:Solution for injection-Route of administration:SC injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Duvakitug
Pharmaceutical form:Solution for Injection-Route of administration:SC injection
Placebo
Pharmaceutical form:Solution for injection-Route of administration:SC injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
16 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Teva Branded Pharmaceutical Products R&D LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Precision Clinical Research-Site Number: 8400059
Coral Springs, Florida, United States
Clinical Research of Osceola
Kissimmee, Florida, United States
Columbus Clinical Services LLc
Miami, Florida, United States
Regis Clinical Research, LLC
Miami, Florida, United States
Bio Research Partner
Miami, Florida, United States
Correa Research Center-Site Number: 8400010
Miami, Florida, United States
Delta Research Partners
Monroe, Louisiana, United States
BVL Clinical Research
Liberty, Missouri, United States
MedTraits NY
Maspeth, New York, United States
Cross Creek Medical Clinic
Fayetteville, North Carolina, United States
Biocentric Health Research Partner
West Columbia, South Carolina, United States
Valley Institute of Research
Harlingen, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Phone: 800-633-1610
Email: [email protected]
Related Links
Access external resources that provide additional context or updates about the study.
EFC18325 Plain Language Results Summary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-521035-37
Identifier Type: REGISTRY
Identifier Source: secondary_id
EFC18325
Identifier Type: -
Identifier Source: org_study_id