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A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Study acronym: SUNSCAPE-2
StatusRecruiting
PhasePhase 3
SponsorSanofi
Started2026-01-16
View on ClinicalTrials.gov ↗
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.

Amendment history 6 changes detected by DataLookout

2026-08-19
minor
Enrollment increased: 671 → 751 participants
2026-07-16
minor
Trial sites expanded: 40 → 46 locations
2026-06-13
minor
Trial sites expanded: 30 → 40 locations
2026-05-23
minor
Trial sites expanded: 20 → 30 locations
2026-04-29
minor
Trial sites expanded: 10 → 20 locations
2026-04-04
minor
Trial sites expanded: 5 → 10 locations
Trial Details
NCT Number NCT07185009
Lead Sponsor Sanofi
Collaborators: Teva Branded Pharmaceutical Products R&D LLC
Conditions Ulcerative Colitis
Enrollment 751 participants
Start Date 2026-01-16
Primary Completion 2028-09-21 (estimated)
Study Completion 2033-04-28 (estimated)
Updated on ClinicalTrials.gov 2026-08-18