Tests duvakitug against placebo in ulcerative colitis
Tests duvakitug versus placebo in adults with moderately to severely active ulcerative colitis.
Plain-language title generated from the registry record
Registry title: An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Key facts
- Where
- Liverpool and Wollongong, AustraliaSee the 2 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderately to severely active ulcerative colitis who did not respond well to earlier treatments. It tests duvakitug against placebo for up to 12 weeks.
- Age
- 18 to 80 years. Where local rules allow, 16 to under 18 years if at Tanner Stage 5 of development.
- Sex
- All sexes can join.
- Disease stage
- Moderately to severely active ulcerative colitis, confirmed at least 3 months before the start of the trial.
- Earlier treatment
- Earlier conventional or advanced therapies did not work well enough, stopped working, or were not tolerated. No earlier anti-TL1A investigational therapy.
Main reasons for not taking part
- Crohn's disease or indeterminate colitis
- Ulcerative proctitis at present
- Bowel surgery (resection) in the past 3 months, or more than 3 bowel resections in the past
- High-grade dysplasia of the digestive tract, past or present
- Not on stable doses of conventional therapies, or taking prohibited medications before the start
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 80 years old?
Source: NCT07184996, who can take part
Where in Australia
- LiverpoolHospital not named in the registryTaking people
- WollongongHospital not named in the registryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sanofi
- Trial code
- NCT07184996
- Record updated
- 23 October 2026
- Original description
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:Read full original descriptionShow less
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.
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.
Inclusion: 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: 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; Participants with Crohn's Disease (CD), indeterminate colitis; Current diagnosis of Ulcerative Proctitis.