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Areata AlopeciaHair lossAestheticChildren's healthSkinLooksmaxxingDrugPhase 3

What this study is

The main purpose of this study is to determine the efficacy and safety of baricitinib for the treatment of severe or very severe alopecia areata (hair loss) in children from 6 years to less than 18 years of age.

The study is divided into 4 periods, a 5-week Screening period, a 36-week Double-Blind Treatment Period, an approximately 2-year Long-term Extension (LTE) Period, and a 4-week Post-treatment Follow-up period. Some individuals may be eligible to receive treatment after completing the LTE, for a maximum of 180 weeks.

What's being tested

  • Baricitinib

    Intervention · DRUG

  • Placebo

    Intervention · DRUG

Both interventions

Administered orally

Study details

Official title
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of Baricitinib in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
Sponsor
Eli Lilly and Company
Conditions
Areata Alopecia · Alopecia · Hypotrichosis · Hair Diseases · Skin Diseases · Pathological Conditions, Anatomical
Enrolling
595 people
Starts
2023-02-27
Est. completion
2033-09
Design
Double-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗