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

Study acronym: SUNSCAPE-1
StatusRecruiting
PhasePhase 3
SponsorSanofi
Started2025-10-08
View on ClinicalTrials.gov ↗
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction 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 35 weeks with: * Screening period * 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction) * 12-week Sub-Study 3 (Extended Induction for non-responders) * 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.

Amendment history 3 changes detected by DataLookout

2026-08-21
minor
Trial sites expanded: 191 → 219 locations
2026-04-25
minor
Trial sites expanded: 140 → 191 locations
2026-03-31
minor
Trial sites expanded: 88 → 140 locations
Trial Details
NCT Number NCT07184996
Lead Sponsor Sanofi
Collaborators: Teva Branded Pharmaceutical Products R&D LLC
Conditions Ulcerative Colitis
Enrollment 980 participants
Start Date 2025-10-08
Primary Completion 2028-05-09 (estimated)
Study Completion 2028-05-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-20