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

Conditions

• Alopecia
• Areata Alopecia
• Hair Diseases
• Hypotrichosis
• Pathological Conditions, Anatomical
• Skin Diseases

Eligibility Criteria

Sex

ALL

Age

6 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Baricitinib — DRUG
  Administered orally
• Placebo — DRUG
  Administered orally

Study Details

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.

Key Dates

Start date

Feb 27, 2023

Status verified

Apr 2026

Primary completion

Mar 31, 2028

Completion

Sep 30, 2033

Study Design

Enrollment

595 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Baricitinib High Dose
  Participants will receive baricitinib high dose orally.
• Experimental: Baricitinib Low Dose
  Participants will receive baricitinib low dose orally.
• Placebo Comparator: Placebo
  Participants will receive placebo

Primary Outcome Measure

Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20 [ Time Frame: Week 36 ]

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (44)

Find similar trials in Birmingham, AL

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