A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata (BRAVE-AA-PEDS)

Study type: Clinical Trials Posting date: 06/20/2023 Last updated: 11/26/2024 Status: Active, Not Recruiting Phase: Phase 3 Country: United States Eligibility:

6 years to 17 years at the age of consent (enrollment will be fully sequential by age group, with adolescents (12 to less than 18 years old) enrolling before children (6 to less than 12 years old)

Drug: Baricitinib (LY3009104) or placebo Administration: Oral Sponsor: Eli Lilly Pharmaceuticals ClinicalTrials.gov link: Click here Location: Multiple locations


Description:

The BRAVE-AA-PEDS is a study testing an oral drug in children and adolescents with severe hair loss, also known as alopecia areata or AA.

What is the BRAVE-AA-PEDS Study?
The study is testing how safe and effective a study drug is for children and adolescents with severe AA. During the 36-week treatment period, participants will receive either the study drug or a placebo (a placebo looks like the study drug but does not contain active medicine). Those taking placebo will be offered the study drug in an extension period.

To qualify for the BRAVE-AA-PEDS STUDY, participants must:*

  • Be at least age 6 and less than 18 years old
  • Have severe AA for at least a year
  • Have a current AA episode that has lasted at least 6 months
  • Have tried at least 1 AA treatment, and it failed

*There are additional requirements as determined by a screening process.

This study is taking place at locations throughout the United States.