A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Study of an Investigational Study Drug for Maintenance Treatment in Ulcerative Colitis
Study Overview
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.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Ulcerative Colitis
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Age: 16 years - 80 years
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Gender: All
Inclusion Criteria:
- 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 Criteria:
- 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.
The purpose of this research study is to learn about the effects and safety of an investigational study drug for adults with moderately to severely active ulcerative colitis. The study is focused on maintenance treatment, which means treatment to help keep symptoms under control after a person has already responded to treatment in an earlier study.
Participants will receive either the investigational study drug or a placebo. A placebo looks like the investigational study drug but does not contain active medication. Some participants may be able to continue into a longer part of the study where everyone receives the investigational study drug.
Who can participate:
Adults with moderately to severely active ulcerative colitis may be able to participate if they:
- Are 18 to 80 years old
- Have already taken part in a specific earlier ulcerative colitis study and had a clinical response, including completing an endoscopy at the end of that study
- Complete the main maintenance part of this study (or took part in another specified related study) if continuing into the longer study period
Study timeline and visits:
Participation may last up to 286 weeks, depending on whether a person continues into the longer study period. There will be up to 32 on-site visits.
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