Tests duvakitug in adults with active Crohn's disease over time
Compares duvakitug with placebo in adults with moderately to severely active Crohn's disease.
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 Crohn's Disease
Key facts
- Where
- Kamakura, Nishinomiya, and Tsu, JapanSee the 3 sites
- Phase
- Phase 3
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: NCT07184944, who can take part
Where in Japan
- KamakuraKamakura, JapanTaking people
- NishinomiyaNishinomiya, JapanTaking people
- TsuTsu, JapanTaking 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?
Trial details
- Who runs it
- Sanofi
- Trial code
- NCT07184944
- Record updated
- 21 October 2026
- Original description
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include: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 Crohn's Disease
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). 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 the Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study
The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 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 STARSCAPE-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 patient's potential participation in a clinical trial.