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
Started

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Record History

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  1. Primary endpoints revised (4) Show 4 more changesShow less
    • Trial sites expanded: 301 → 432 locations
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 10 of 17 entries
    • Collaborators: details revised at 1 of 1 entry
  2. Trial sites expanded: 259 → 301 locationsv12
  3. Trial sites expanded: 196 → 259 locationsv11
  4. Trial sites expanded: 130 → 196 locationsv10
  5. Trial sites expanded: 85 → 130 locationsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 71 to 85v8
  2. Study sites: 57 to 71v7
  3. Study sites: 30 to 57v6
  4. Study sites: 28 to 30v5
  5. Study sites: 20 to 28v4
  6. Study sites: 3 to 20v3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    v2
  1. Study First Submitted
  • 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
285 trials monitored
See 12 trials at risk
Crohn's Disease
643 trials monitored
See 36 trials at risk
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.
Trial Details
NCT Number NCT07184931
Lead Sponsor Sanofi
Collaborators: Teva Branded Pharmaceutical Products R&D LLC
Conditions
(from sponsor)		 Crohn's Disease
Related terms Crohn Disease
Enrollment 980 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov