Long-Term Study of Ritlecitinib for Severe Alopecia Areata in Children
This study is looking into the long-term safety and effects of ritlecitinib, a medicine taken by mouth, for children aged 6 to 14 with severe alopecia areata (a condition causing hair loss). Participants must have previously completed one of Pfizer's pediatric alopecia areata studies (B7981027 or B7981031). For those coming from study B7981031, you need to have at least 50% scalp hair loss. All participants will receive either a higher or lower dose of ritlecitinib. The main goal is to understand how safe ritlecitinib is over time, looking at any side effects that might occur for up to approximately 3 years.
- Study design
- This is a long-term extension study, meaning it follows participants from previous ritlecitinib studies. It is a double-blind study, which means neither you nor your doctor will know if you are receiving the higher or lower dose of ritlecitinib. The study plans to enroll at least 140 participants.
- What's involved
- Participants will receive ritlecitinib as oral capsules. The study will monitor for side effects from the time you agree to participate until at least 28 days after your last dose, for up to approximately 3 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 28 days after their last dose of ritlecitinib, for a total period of up to approximately 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.
At a glance
Conditions
Where it's being run
41 sites across 25 statesStudy leadership
- Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer
Who to contact
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What this trial measures
- Incidence of treatment-emergent adverse events (AEs).From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 3 years).
- Incidence of Serious Adverse Events (SAEs) and AEs leading to permanent discontinuation from the study.From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 3 years).