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Baricitinib for Alopecia Areata in Children and Adolescents

This study is testing a medication called baricitinib to see how well and how safely it treats severe hair loss (alopecia areata) in children and adolescents aged 6 to under 18 years old. Participants will receive either baricitinib or a placebo (an inactive substance) by mouth. The main goal is to see what percentage of participants achieve significant hair regrowth, measured by a special tool (SALT score) at 36 weeks. To join, you must have had severe alopecia areata for at least one year, with a current episode lasting at least six months, and a SALT score of 50% or higher. The study is currently recruiting, with adolescents enrolling before younger children.

Study design
This is an interventional study involving approximately 595 participants. It includes a double-blind treatment period, meaning neither you nor your doctor will know if you are receiving baricitinib or placebo.
What's involved
The study involves a 5-week screening period, a 36-week treatment period, an approximately 2-year long-term extension, and a 4-week follow-up after treatment. Some participants might receive treatment for up to 180 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 4 weeks after their treatment period ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05723198

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

Recruiting
PHASE3Ages 6–17InterventionalTreatment
Eli Lilly and Company
~595 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:BaricitinibPlacebo

At a glance

Recruiting sites
99 of 127 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20
Measured over Week 36

Conditions

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

Explore related trials

Alopecia

Where it's being run

127 sites across 36 states
Poland14
South Korea14
Argentina8
Germany8
Japan8
Florida7
Canada6
France6

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20Week 36