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
Eli Lilly and Company
Summary
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 Period, and a 4-week Post-treatment Follow-up period.
Eligibility
- Age range
- 6–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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). * Have severe areata alopecia (AA) for at least 1 year * Diagnosis for at least 1 year * Current AA episode of at least 6 months' duration * SALT score ≥50% at screening and baseline * History of trial and failure with at least 1 available treatment (topical or other) for AA * History of psychological counseling related to AA * Current episode of severe AA of less than 8 years. * Note: Participants who have severe A…
Interventions
- DrugBaricitinib
Administered orally
- DrugPlacebo
Administered orally
Locations (127)
- Total Skin and Beauty Dermatology Center, PCBirmingham, Alabama
- University of Alabama at BirminghamBirmingham, Alabama
- Investigate MDScottsdale, Arizona
- California Dermatology & Clinical Research InstituteEncinitas, California
- Dermatology Research AssociatesLos Angeles, California
- University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent DermatologySan Diego, California