A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.

Study acronym: B7981028
StatusRecruiting
PhasePhase 3
SponsorPfizer
Started

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Record History

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  1. Minor Trial sites expanded: 41 → 67 locations
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 2 of 10 entries
  2. Minor Study sites: 4 to 41v5
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Primary and study completion dates: May 31, 2030 to Jun 26, 2030
    • Start date changed from estimate of Aug 29, 2025 to Sep 10, 2025
    v4
  4. Minor Start date: Aug 15, 2025 to Aug 29, 2025v3
  5. Notable Start date: Jul 14, 2025 to Aug 15, 2025v2
  6. Minor 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.
438 trials monitored
See 32 trials at risk
The purpose of this clinical trial is to learn about long-term safety and long-term effects of the study medicine (called ritlecitinib) for the potential treatment of severe alopecia areata, a condition that causes hair loss. This study is seeking participants who have: * previously completed one of Pfizer's pediatric studies for Alopecia Areata (B7981027 or B7981031). * at least 50% scalp hair loss due to alopecia areata (for participants enrolling from the study B7981031). * received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports. All participants in this study will receive the study medicine (ritlecitinib). Participants who received ritlecitinib higher or lower doses in the parent Study B7981027 will continue receiving the same ritlecitinib dose in this trial. Participants who received placebo in the parent Study B7981027 and all participants from parent Study B7981031 will receive either higher or lower dose of ritlecitinib in this trial. The study medicine is a capsule that is taken by mouth. It is taken 1 time each day at home. The study will help see if ritlecitinib is safe and effective. Participants will take part in this study for a duration of up to 3 years (36 months). During this time, they will have 17 study visits at the study clinic. The study team will also call participants once a month over the phone.
Trial Details
NCT Number NCT07029828
Lead Sponsor Pfizer
Conditions
(from sponsor)
Severe Alopecia Areata
Related terms Alopecia Areata
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov