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.
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
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
Sanofi
Lead sponsor
Teva Branded Pharmaceutical Products R&D LLC
Collaborator