A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata

Condition(s) studied

Investigational drug(s) / intervention(s)

Ritlecitinib higher dose: Study intervention will be provided as oral capsules centrally by the sponsor in high-density polyethylene (HDPE) bottles.

Ritlecitinib lower dose: Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.

Placebo: Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.

Study summary

The purpose of this study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the possible treatment of severe alopecia areata. Alopecia areata is a condition that causes hair loss.

This study is seeking participants who have:

* at least 50% scalp hair loss due to alopecia areata.
* received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports.
* history of clinical response failure to alopecia areata treatment (for children in EU/UK only).

All participants in this study will receive either study medicine (ritlecitinib) or placebo. A placebo does not have any medicine in it but looks just like the medicine being studied.

One-third of participants will receive ritlecitinib higher dose, one-third participants will receive ritlecitinib lower dose, and one-third participants will receive placebo.

The study medicine is a capsule that is taken by mouth. It is taken once each day at home.

The study will compare the experiences of participants receiving ritlecitinib to participants receiving placebo. This will help see if ritlecitinib is safe and effective.

Participants will take part in this study for 6 months. During this time, they will have 8 study visits at the study clinic. The study team will also call participants about 8 times over the phone.

Eligibility

Primary outcome measure(s)

• For US and Countries Following US Analysis Plan: Response based on achieving an absolute Severity of Alopecia Tool (SALT) score ≤20. — Week 24
  The difference in proportions of participants with the SALT ≤20 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.
• For EU/UK and Countries Following EU/UK Analysis Plan: Response based on achieving an absolute SALT score ≤10. — Week 24
  The difference in proportions of participants with the SALT ≤10 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.

Trial sites (83)

+ 43 more sites — see the full list on the official registry below.

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