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Taking people in BulgariaPhase 3

Tests duvakitug to maintain remission in ulcerative colitis

Tests duvakitug against placebo in adults with active ulcerative colitis.

Key facts

Who runs it
Sanofi
Where
Gorna Oryahovitsa and Sofia, BulgariaSee the 2 sitesAlso in 30 other countries, 169 sites
Registry title
A Maintenance 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
751 people, planned
Started
16 Jan 2026
Expected to end
28 Apr 2033
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Duvakitug
  • Placebo
Record updated
16 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 already took part in the earlier SUNSCAPE-1 study and responded to treatment. It tests duvakitug against placebo as ongoing treatment.

Age
18 to 80 years. Where local rules allow, 16 to under 18 years if they have reached Tanner stage 5 of development.
Sex
All sexes can join.
Disease stage
Moderately to severely active ulcerative colitis.
Earlier treatment
For the main maintenance part, people must have had a clinical response and an endoscopy at the end of SUNSCAPE-1. For the extension part, people must have finished the maintenance part or the TV48574-IMM-20038 Study.

Main reasons for not taking part

  • Medical or compliance conditions that the investigator judges unsuitable for the study
  • Known hypersensitivity to duvakitug that makes the person unsuitable for the study, in the investigator's view

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to <18 years of age who meet the definition of Tanner stage 5 for development)
  • Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of SUNSCAPE-1
  • OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study

Who cannot take part

  • Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator
  • Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator; The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial

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 Bulgaria

Also in 30 other countries, 169 sites

  • Gorna Oryahovitsa, Oblast Veliko TirnovoHospital not named in the registryTaking people
  • SofiaHospital not named in the registryTaking people

About the trial

What the trial wants to find out

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC).

Read full original descriptionShow less

Study details include:

The study duration may be up to 286 weeks including:

* 40-week Pivotal Maintenance Sub-Study * 240-week Open-Label Extension (OLE) Sub-Study * 45-day Follow-up Visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.

The treatment duration may be up to 280 weeks including:

* 40 weeks in Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study

The total number of on-site visit will be up to 32:

* 21 visits in the Pivotal Maintenance Sub-Study. * 11 visits in the OLE Sub-Study.

The 4 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

  • Duvakitug - dose 3Treatment 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 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Plain-language title
Tests duvakitug to maintain remission 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 NCT07185009, who can take part
Record updated
16 October 2026