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An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
NCT07184931 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Duvakitug
Study Locations (20)
California
- Kagoshima IBD Gastroenterology Clinic - Site Number: 8400008 — Canoga Park
- Southern California GI & Liver Centers-Site Number: 8400062 — Coronado
- GMC Clinical Research, LLC-Site Number: 8400113 — Folsom
- TLC Clinical Research Inc.: 8400030 — Los Angeles
- United Medical Doctors CA-Site Number: 8400044 — Murrieta
- Prospective Research Innovations Inc.: 8400017 — Rancho Cucamonga
- Valiance Clinical Research - Tarzana: 8400023 — Tarzana
- Clinical Trials Management Services-Site Number: 8400047 — Thousand Oaks
- Amicis Research Center-Valencia-Site Number: 8400064 — Valencia
- Om Research, LLC - Victorville - Site Number: 8400022 — Victorville
Florida
- Precision Clinical Research: 8400059 — Coral Springs
- Sarkis Clinical Trials-Ocala-Site Number: 8400048 — Gainesville
- Clinical Research of Osceola-Site Number: 8400013 — Kissimmee
- Columbus Clinical Services LLc-Site Number: 8400038 — Miami
- Regis Clinical Research, LLC-Site Number: 8400041 — Miami
Arizona
- Onyx Clinical Research - Site Number: 8400021 — Peoria
- One of a Kind Clinical Research Center LLC-Site Number: 8400061 — Scottsdale
- Del Sol Research Management, LLC-Site Number: 8400012 — Tucson
Arkansas
- Preferred Research Partners: 8400018 — Little Rock
Colorado
- Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039 — Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 980 participants |
| Start Date | 2025-10-01 |
| Est. Completion | 2029-05-14 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07184931
The ClinicalTrials.gov registry entry for NCT07184931 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 980 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07184931 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07184931 about?
NCT07184931 is a clinical study titled "An Induction Study to Investigate 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 ...
What is the current status of trial NCT07184931?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 980 participants. The study started on 2025-10-01. Estimated completion is 2029-05-14.
What conditions does trial NCT07184931 study?
This clinical trial studies the following conditions: Crohn's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07184931?
The interventions under investigation include: Placebo (DRUG), Duvakitug (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07184931?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07184931 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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