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Treatment of severe alopecia areata in children using baricitinib

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

Phase 3 Interventional Eli Lilly and Company · NCT05723198

This study is testing if the medication baricitinib can help children aged 6 to under 18 with severe alopecia areata by seeing how well it works and if it’s safe over a long period.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment595 (estimated)
Ages6 Years to 17 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionschemotherapy, baricitinib
Locations127 sites (Birmingham, Alabama and 126 other locations)
Trial IDNCT05723198 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of baricitinib in treating severe or very severe alopecia areata in children aged 6 to less than 18 years. It consists of a 5-week screening period, followed by a 36-week double-blind treatment phase where participants receive either baricitinib or a placebo. After this, there is a long-term extension period lasting approximately 2 years, and a 4-week post-treatment follow-up. The study aims to provide insights into the long-term effects and benefits of baricitinib for this condition.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 to less than 18 years with a diagnosis of severe alopecia areata lasting at least one year.

Not a fit: Patients with other forms of alopecia or those who have had severe alopecia areata for 8 years or more without any episodes of regrowth may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve hair regrowth and quality of life for children suffering from severe alopecia areata.

How similar studies have performed: Previous studies have shown promising results with baricitinib for alopecia areata, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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 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 Criteria:

* 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 this trial is running

Birmingham, Alabama and 126 other locations

+77 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Areata AlopeciaAlopeciaHypotrichosisHair DiseasesSkin DiseasesPathological Conditions, Anatomical
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.