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

Recruiting Phase 3 Interventional Study
Areata Alopecia Alopecia Hypotrichosis Hair Diseases Skin Diseases Pathological Conditions, Anatomical
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
6 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
595 (estimated)
Sponsor
Eli Lilly and Company · Industry
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About This Trial
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-treatm…
Trial Locations
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Eligibility Criteria
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 …
Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

LillyTrials@Lilly.com

CONTACT

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

CONTACT