Treatment of severe alopecia areata in children using baricitinib

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Total Skin and Beauty Dermatology Center, PC
  Birmingham, Alabama, United States Recruiting
• Investigate MD
  Scottsdale, Arizona, United States Recruiting
• Dermatology Research Associates
  Los Angeles, California, United States Recruiting
• University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
  San Diego, California, United States Recruiting
• The Permanente Medical Group, Inc.
  San Francisco, California, United States Recruiting
• Southern California Dermatology, Inc.
  Santa Ana, California, United States Recruiting

+77 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Registry for systemic treatments of alopecia areata

  This study is trying to see how well different systemic treatments work for people with moderate-to-severe alopecia areata, alopecia totalis, and alopecia universalis.

  Recruiting Erasmus Medical Center · Rotterdam · NCT06283316

• Safety and drug level study of multiple doses of upadacitinib, tofacitinib, and baricitinib in healthy adults

  This early-phase study tests how different doses of upadacitinib, tofacitinib, and baricitinib behave in healthy adults to understand safety and how the drugs act in the body.

  Recruiting Phase 1 AbbVie · Grayslake, Illinois · NCT07843693

• Does driving with UVA exposure affect facial skin hydration on the left vs right cheek in Florida drivers

  This observational study tests whether Florida women who drive more show less hydration on their left cheek (exposed to UVA through the driver-side window) compared with their right cheek.

  Recruiting IAS Skin Care · Orlando, Florida · NCT07764809

• Alopecia Areata: looking at ferroptosis markers in blood

  This study tests whether levels of GPX4 and MDA in blood differ between people with alopecia areata and healthy controls.

  Recruiting Istanbul Training and Research Hospital · Istanbul, Cerrahpasa Mahallesi · NCT07733063

• Topical KB111 for Hailey-Hailey Disease (early phase, kids and adults)

  This study tests whether a topical KB111 treatment is safe and helps with lesions in people with Hailey-Hailey disease, including adolescents and adults.

  Recruiting Early Phase 1 Krystal Biotech, Inc. · Miami, Florida · NCT07717346

• Turning anonymous symptom descriptions into structured biological signals with OpenGenome

  This project tries to turn adults' anonymous free-text symptom descriptions submitted to OpenGenome into structured, literature-grounded biological signals using PubMed and ClinicalTrials.gov sources and a constrained reasoning model.

  Recruiting OpenGenome · Friedrichshain, State of Berlin · NCT07578610

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.