drugset / Trial / NCT05650333

A Study to Learn About the Study Medicine (Called Ritlecitinib) For the Potential Treatment of Severe Alopecia Areata (AA) In Children 6 To Less Than 12 Years of Age

NCT05650333

Phase 1 Completed 15 enrolled Pfizer
NaSingle-groupOpen-labelOther

Summary

The purpose of the study is to evaluate the pharmacokinetics (how the medicine is changed and eliminated from your body after you take it) and pharmacodynamics (effects of the medicine in the body) of the study medicine (called Ritlecitinib) in children of 6 to \<12 years of age with Alopecia Areata, a condition of scalp hair loss. 12 children with alopecia areata will be participating in this study. All participants will receive study medicine with a dose of 20 milligram (mg) orally once daily for 7 days. 5 blood samples will be collected on day 7 for pharmacokinetic evaluation and 2 blood samples each at screening and on Day 7 will be collected for pharmacodynamic evaluation. Participants will take part in the study for about 10 weeks.

Timeline

Start
2023-03-02
Primary completion
2023-08-11
Completion
2023-08-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ritlecitinib Small molecule 20 mg Oral

Indications