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).
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.