A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema

StatusRecruiting
PhasePhase 3
SponsorPfizer
Started

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Record History

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  1. Notable Primary endpoints: details revised at 1 of 2 entries
    • Study sites: 46 to 47
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 1 of 3 entries
  2. Minor Trial sites expanded: 43 → 46 locationsv18
  3. Minor Study sites: 42 to 43v17
  4. Minor Study sites: 41 to 42v16
  5. Minor Study sites: 40 to 41v15
Show 13 earlier versionsHide 13 earlier versions
  1. Minor Study sites: 39 to 40v14
  2. Minor Study sites: 38 to 39v13
  3. Minor Study sites: 31 to 38v12
  4. Minor Study sites: 27 to 31v11
  5. Minor Study sites: 21 to 27v10
  6. Minor Study sites: 14 to 21v9
  7. Minor Study sites: 13 to 14v8
  8. Minor Study sites: 12 to 13v7
  9. Minor Study sites: 11 to 12
    • Start date changed from estimate of Jun 30, 2025 to Jul 24, 2025
    v6
  10. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 8 to 11
    v5
  11. Minor Study sites: 0 to 8
    • Start date: Jun 16, 2025 to Jun 30, 2025
    v4
  12. Re-verified, no change to tracked fieldsv3
  13. Minor Primary and study completion dates: Mar 24, 2027 to May 2, 2027v2
  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.
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This research study is being conducted to find out if the test medicine, abrocitinib, improves eczema and is safe for children 6 to \<12 years of age who have moderate-to-severe eczema. Research study participants who meet the study criteria will be assigned by chance (like the flip of a coin) to receive either abrocitinib test medicine or placebo (pretend medicine that looks just like the test medicine) for 16 weeks. The study will last for about 24 weeks in total.
Trial Details
NCT Number NCT06807268
Lead Sponsor Pfizer
Conditions
(from sponsor)
Eczema
Related terms Dermatitis, Eczema
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov