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A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis

StatusRecruiting
PhasePhase 3
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study sites: 14 to 15
    • Eligibility criteria expanded, about 33 words
  2. Study sites: 13 to 14v14
  3. Study sites: 14 to 13v13
  4. Study sites: 13 to 14v12
  5. Study sites: 12 to 13v11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 11 to 12v10
  2. Study sites: 9 to 11v9
  3. Study sites: 7 to 9v8
  4. Study sites revised (7)v7
  5. Study sites: 6 to 7v6
  6. Study sites: 4 to 6v5
  7. Study sites: 3 to 4v4
  8. Study sites: 2 to 3
    • Start date changed from estimate of May 1, 2024 to May 15, 2024
    v3
  9. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 28, 2024 to May 1, 2024
    • Study sites: 0 to 2
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study. The study consists of 3 periods: * Screening period: 2 to 4 weeks. * Treatment period: 24 weeks. * Post-intervention follow-up period: 16 weeks. The study duration will be approximately 42 to 44 weeks for each participant (including screening, treatment, and follow-up periods). The total number of planned study visits for each participant will be 6.
Trial Details
NCT Number NCT06293053
Lead Sponsor Sanofi
Collaborators: Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Prurigo Nodularis
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov