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
Started

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Record History

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  1. Trial sites expanded: 55 → 171 locations
  2. Trial sites expanded: 46 → 55 locations
    • Secondary endpoints: details revised at 7 of 16 entries
    • Collaborators: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 5 words
  3. Enrollment increased: 671 → 751 participantsv10
  4. Trial sites expanded: 40 → 46 locationsv9
  5. Trial sites expanded: 30 → 40 locationsv8
  6. Trial sites expanded: 20 → 30 locationsv7
  7. Trial sites expanded: 10 → 20 locationsv6
  8. Trial sites expanded: 5 → 10 locationsv5
  9. Study sites: 4 to 5v4
  10. Study sites: 2 to 4
    • Start date changed from estimate of Jan 7, 2026 to Jan 16, 2026
    v3
  11. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    v2
  12. 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
Ulcerative Colitis
627 trials monitored
See 40 trials at risk
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.
Trial Details
NCT Number NCT07185009
Lead Sponsor Sanofi
Collaborators: Teva Branded Pharmaceutical Products R&D LLC
Conditions
(from sponsor)		 Ulcerative Colitis
Related terms Colitis, Ulcerative
Enrollment 751 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov