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
Started

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Record History

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  1. Trial sites expanded: 219 → 240 locations
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 6 of 16 entries
    • Collaborators: details revised at 1 of 1 entry
  2. Trial sites expanded: 191 → 219 locationsv11
  3. Trial sites expanded: 140 → 191 locationsv10
  4. Trial sites expanded: 88 → 140 locationsv9
  5. Study sites: 74 to 88v8
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  1. Study sites: 57 to 74v7
  2. Study sites: 29 to 57v6
  3. Study sites: 13 to 29
    • Secondary endpoints: details revised at 1 of 16 entries
    v5
  4. Study sites: 2 to 13v4
  5. Start date changed from estimate of Oct 1, 2025 to Oct 8, 2025v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    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
286 trials monitored
See 13 trials at risk
Ulcerative Colitis
629 trials monitored
See 41 trials at risk
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.
Trial Details
NCT Number NCT07184996
Lead Sponsor Sanofi
Collaborators: Teva Branded Pharmaceutical Products R&D LLC
Conditions
(from sponsor)		 Ulcerative Colitis
Related terms Colitis, Ulcerative
Enrollment 980 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov