A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema

StatusRecruiting
PhasePhase 3
SponsorPfizer
Started

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Trial flagged as At Risk
Enrollment reduced 10% 500 → 450 participants
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Record History

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  1. Enrollment reduced: 500 → 450 participants
  2. Study sites: 41 to 39
    • Eligibility criteria expanded, about 37 words
    • Secondary endpoints: details revised at 8 of 17 entries
    • Study description revised
  3. Trial sites expanded: 38 → 41 locationsv17
  4. Study sites: 37 to 38v16
  5. Trial sites expanded: 31 → 37 locationsv15
  6. Trial sites expanded: 26 → 31 locationsv14
  7. Study sites: 18 to 26v13
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 13 to 18
    v12
  9. Study sites: 7 to 13v11
  10. Study sites: 4 to 7v10
  11. Study sites: 2 to 4
    • Start date: Dec 11, 2025 to Dec 2, 2025
    v9
  12. Re-verified, no change to tracked fieldsv8
  13. Start date: Nov 3, 2025 to Dec 11, 2025v7
  14. Study sites: 0 to 2v6
  15. 2 versions Re-verified since May 12, 2025, no change to tracked fieldsv4-v5
  16. Primary endpoints: 2 to 1
    • Secondary endpoints: 15 to 17
    v3
  17. Primary and study completion dates: Jan 17, 2032 to Feb 22, 2032v2
  18. 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.
Pfizer
438 trials monitored
See 32 trials at risk
Atopic Dermatitis
500 trials monitored
See 18 trials at risk
This 24-month study will assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis. The study will enroll two groups: participants who have completed other abrocitinib studies and participants who have never participated in abrocitinib studies.
Trial Details
NCT Number NCT06807281
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Atopic Dermatitis
Related terms Dermatitis, Atopic, Eczema
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov