Tests duvakitug to maintain remission in ulcerative colitis
Tests duvakitug against placebo in adults with active ulcerative colitis.
Plain-language title generated from the registry record
Registry title: A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Key facts
- Where
- Beijing, Chengdu, Guangzhou, Hefei, Huizhou, Kunming, Shanghai, and Wuxi, ChinaSee the 8 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 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
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: NCT07185009, who can take part
Where in China
- BeijingHospital not named in the registryTaking people
- Chengdu, SichuanHospital not named in the registryTaking people
- GuangzhouHospital not named in the registryTaking people
- HefeiHospital not named in the registryTaking people
- Huizhou, GuangdongHospital not named in the registryTaking people
- KunmingHospital not named in the registryTaking people
- ShanghaiHospital not named in the registryTaking people
- Wuxi, JiangsuHospital 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
- NCT07185009
- Record updated
- 16 October 2026
- Original description
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
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
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).
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.
Inclusion: 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.
Exclusion: 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.