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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Areata Alopecia, Alopecia, Hypotrichosis, Hair Diseases, Skin Diseases, Pathological Conditions, Anatomical

In brief

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 facts

Study ID

NCT05723198

Run by

Eli Lilly and Company

People needed

595

Starts

2023-02-27

Expected to finish

2033-09-01

Last updated by the study team

2026-07-17

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 AA for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years.

You may not qualify if…

• Primarily "diffuse" type of AA (characterized by diffuse hair shedding).
• Are currently experiencing other forms of alopecia including, but not limited to trichotillomania, telogen effluvium, chemotherapy-induced hair loss, or any other concomitant conditions (for example, tinea capitis, psoriasis, lupus erythematosus, or secondary syphilis) that would interfere with evaluations of the effect of study medication on AA.
• Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden
• Have uncontrolled arterial hypertension
• Have had major surgery within 8 weeks prior to screening or will require major surgery during the study
• Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking IP or interfere with the interpretation of data.
• Have a positive test for hepatitis B virus (HBV) infection
• Have hepatitis C virus (HCV) infection (positive for anti hepatitis C antibody with confirmed presence of HCV ribonucleic acid [RNA]).
• Have evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.

Where it is running

• Vital Prospects Clinical Research Institute, P.C. — Tulsa, Oklahoma, United States (enrolling)
• International Clinical Research - Tennessee (IC Research) — Murfreesboro, Tennessee, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• Bexley Dermatology Research — Bexley, Ohio, United States (enrolling)
• Northwest Dermatology Institute — Portland, Oregon, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• Southern California Dermatology, Inc. — Santa Ana, California, United States (enrolling)
• Advanced Skin Research Center — Omaha, Nebraska, United States (enrolling)
• Dermatology Research Associates — Los Angeles, California, United States (enrolling)
• Dermatology Specialists of Charlotte — Charlotte, North Carolina, United States (enrolling)
• University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology — San Diego, California, United States (enrolling)
• Investigate MD — Scottsdale, Arizona, United States (enrolling)
• Solutions Through Advanced Research, Inc. — Jacksonville, Florida, United States (enrolling)
• The Permanente Medical Group, Inc. — San Francisco, California, United States (enrolling)
• Pediatric Skin Research, LLC — Miami, Florida, United States (enrolling)
• Skin Care Physicians of Georgia — Macon, Georgia, United States (enrolling)
• Total Skin and Beauty Dermatology Center, PC — Birmingham, Alabama, United States (enrolling)
• Northshore University Healthsystem — Skokie, Illinois, United States (enrolling)
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States (enrolling)
• The South Bend Clinic Center for Research — South Bend, Indiana, United States (enrolling)
• DermAssociates PC. — Rockville, Maryland, United States (enrolling)
• Michigan Center for Research Company — Clarkston, Michigan, United States (enrolling)
• University of Minnesota Medical School — Minneapolis, Minnesota, United States (enrolling)
• MediSearch Clinical Trials — Saint Joseph, Missouri, United States (enrolling)
• Pediatric Dermatology of North Texas — Grapevine, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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