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An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

Study acronym: STARSCAPE-1
StatusRecruiting
PhasePhase 3
SponsorSanofi
Started2025-10-01
View on ClinicalTrials.gov ↗
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include: The study duration may be up to 35 weeks with: * Up to 5-week 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). * 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.

Amendment history 4 changes detected by DataLookout

2026-07-02
minor
Trial sites expanded: 259 → 301 locations
2026-05-30
minor
Trial sites expanded: 196 → 259 locations
2026-04-28
minor
Trial sites expanded: 130 → 196 locations
2026-04-01
minor
Trial sites expanded: 85 → 130 locations
Trial Details
NCT Number NCT07184931
Lead Sponsor Sanofi
Collaborators: Teva Branded Pharmaceutical Products R&D LLC
Conditions Crohn's Disease
Enrollment 980 participants
Start Date 2025-10-01
Primary Completion 2029-05-14 (estimated)
Study Completion 2029-05-14 (estimated)
Updated on ClinicalTrials.gov 2026-07-01