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

Study acronym: STARSCAPE-2
StatusRecruiting
PhasePhase 3
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary endpoints: details revised at 2 of 3 entries Show 4 more changesShow less
    • Trial sites expanded: 35 → 90 locations
    • Secondary endpoints: details revised at 13 of 19 entries
    • Collaborators: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 5 words
  2. Trial sites expanded: 15 → 35 locationsv8
  3. Enrollment increased: 671 → 751 participants
    • Study sites: 13 to 15
    v7
  4. Trial sites expanded: 7 → 12 locationsv6
  5. Study sites: 7 to 12v5
  6. Trial sites expanded: 2 → 7 locationsv4
  7. Study sites: 3 to 2
    • Start date changed from estimate of Jan 29, 2026 to Jan 22, 2026
    • Eligibility criteria revised
    v3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    v2
  9. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
284 trials monitored
See 12 trials at risk
Crohn's Disease
642 trials monitored
See 34 trials at risk
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). 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 the Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study
Trial Details
NCT Number NCT07184944
Lead Sponsor Sanofi
Collaborators: Teva Branded Pharmaceutical Products R&D LLC
Conditions
(from sponsor)		 Crohn's Disease
Related terms Crohn Disease
Enrollment 751 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov