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A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

Study acronym: DUET ENCORE-CD
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC
    • Trial sites expanded: 142 → 252 locations
    • Secondary endpoints: 10 to 12
    • Eligibility criteria shortened, about 2 words
  2. Trial sites expanded: 55 → 142 locationsv5
  3. Trial sites expanded: 22 → 55 locationsv4
  4. Trial sites expanded: 5 → 22 locationsv3
  5. Recruitment opened
    • Trial sites expanded: 0 → 5 locations
    • Start date changed from estimate of May 29, 2026 to May 22, 2026
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active Crohn's disease (a long-term, progressive \[worsens with time\] and life-threatening disease of the intestine).
Trial Details
NCT Number NCT07577843
Lead Sponsor Janssen Research & Development, LLC
Conditions
(from sponsor)		 Crohn Disease
Related terms Crohn Disease
Enrollment 460 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov