A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis

StatusCompleted
PhasePhase 3
SponsorAmgen
Started

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Record History

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  1. Trial completed
    • Enrollment increased: 17 → 21 participants
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 1 of 9 entries
  2. Study completion date: Sep 6, 2026 to Sep 3, 2026v18
  3. Re-verified, no change to tracked fieldsv17
  4. Enrollment target: 21 to 17
    • Primary completion date: Nov 25, 2025 to Nov 20, 2025
    v16
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 33 to confirmed 21
    • Site details revised at 29 of 29 sites
    v15
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  1. Study sites revised (29)v14
  2. Study sites: 28 to 29v13
  3. Study sites: 27 to 28v12
  4. Study sites: 26 to 27v11
  5. Study sites: 25 to 26v10
  6. Re-verified, no change to tracked fieldsv9
  7. Study sites revised (25)v8
  8. Re-verified, no change to tracked fieldsv7
  9. Primary completion date: Nov 20, 2025 to Nov 25, 2025
    • Study completion date: Oct 2, 2026 to Sep 6, 2026
    • Study sites revised (25)
    v6
  10. Study sites: 24 to 25v5
  11. Study sites: 23 to 24v4
  12. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 17 to 23
    • Start date changed from estimate of Feb 28, 2023 to Jan 25, 2023
    v3
  13. Start date: Dec 31, 2022 to Feb 28, 2023
    • Study sites: 6 to 17
    • Primary completion date: Jul 11, 2025 to Nov 20, 2025
    • Study completion date: May 24, 2026 to Oct 2, 2026
    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.
Amgen
169 trials monitored
See 11 trials at risk
Psoriasis
593 trials monitored
See 24 trials at risk
The primary objective of this study is to evaluate the efficacy of apremilast in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis.
Trial Details
NCT Number NCT05565560
Lead Sponsor Amgen
Conditions
(from sponsor)		 Plaque Psoriasis
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov