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Taking people in ItalyPhase 3

Tests duvakitug against placebo in ulcerative colitis

Tests duvakitug versus placebo in adults with moderately to severely active ulcerative colitis.

Key facts

Who runs it
Sanofi
Where
Legnano and Milan, ItalySee the 2 sitesAlso in 24 other countries, 238 sites
Registry title
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Status
Recruiting
Phase
Phase 3
People taking part
980 people, planned
Started
8 Oct 2025
Expected to end
9 May 2028
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Duvakitug
  • Placebo
Record updated
23 October 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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 cannot take part

  • 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

Check if you might fit

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?

Where in Italy

Also in 24 other countries, 238 sites

  • LegnanoHospital not named in the registryTaking people
  • MilanHospital not named in the registryTaking people

About the trial

What the trial wants to find out

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

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.

The 3 groups in the trial

  • Duvakitug - dose 1Treatment being tested

    Subcutaneous (SC) injection as per protocol

    Treatment: Duvakitug

  • Duvakitug - dose 2Treatment being tested

    SC injection as per protocol

    Treatment: Duvakitug

  • PlaceboPlacebo, for comparison

    SC injection as per protocol

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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.
Plain-language title
Tests duvakitug against placebo in ulcerative colitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07184996, who can take part
Record updated
23 October 2026