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Clinical Trials in the USA / NCT05723198
Recruiting Phase 3

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

NCT05723198 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2023-02-27
Last updated
2026-09-08

Condition(s) studied

Areata AlopeciaAlopeciaHypotrichosisHair DiseasesSkin DiseasesPathological Conditions, Anatomical

Investigational drug(s) / intervention(s)

BaricitinibPlacebo

Baricitinib: Administered orally

Placebo: Administered orally

Study summary

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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (127)

FacilityCityRegionStatus
Total Skin and Beauty Dermatology Center, PC Birmingham Alabama Recruiting
University of Alabama at Birmingham Birmingham Alabama Not Yet Recruiting
Investigate MD Scottsdale Arizona Recruiting
California Dermatology & Clinical Research Institute Encinitas California Not Yet Recruiting
Dermatology Research Associates Los Angeles California Recruiting
University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology San Diego California Recruiting
The Permanente Medical Group, Inc. San Francisco California Recruiting
Southern California Dermatology, Inc. Santa Ana California Recruiting
Dermatology Physicians of Connecticut Fairfield Connecticut Not Yet Recruiting
Skin Care Research, Inc Boca Raton Florida Not Yet Recruiting
Florida Academic Centers Research and Education, LLC Coral Gables Florida Completed
D&H Doral Research Center LLC Doral Florida Not Yet Recruiting
Skin Care Research, Inc Hollywood Florida Not Yet Recruiting
Solutions Through Advanced Research, Inc. Jacksonville Florida Recruiting
University of Miami Miller School of Medicine Miami Florida Not Yet Recruiting
Pediatric Skin Research, LLC Miami Florida Recruiting
Skin Care Physicians of Georgia Macon Georgia Recruiting
Northwestern University Chicago Illinois Not Yet Recruiting
Northshore University Healthsystem Skokie Illinois Recruiting
Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana Recruiting
The South Bend Clinic Center for Research South Bend Indiana Recruiting
DermAssociates PC. Rockville Maryland Recruiting
Michigan Center for Research Company Clarkston Michigan Recruiting
University of Minnesota Medical School Minneapolis Minnesota Recruiting
MediSearch Clinical Trials Saint Joseph Missouri Recruiting
Advanced Skin Research Center Omaha Nebraska Recruiting
Montefiore Medical Center The Bronx New York Recruiting
Dermatology Specialists of Charlotte Charlotte North Carolina Recruiting
OnSite Clinical Solutions Charlotte North Carolina Completed
Bexley Dermatology Research Bexley Ohio Recruiting
Cincinnati Childrens Hospital Medical Center Cincinnati Ohio Not Yet Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Not Yet Recruiting
Vital Prospects Clinical Research Institute, P.C. Tulsa Oklahoma Recruiting
Northwest Dermatology Institute Portland Oregon Recruiting
The Pennsylvania Centre for Dermatology, LLC Exton Pennsylvania Completed
Medical University of South Carolina Charleston South Carolina Recruiting
International Clinical Research - Tennessee (IC Research) Murfreesboro Tennessee Recruiting
Dermatology Treatment and Research Center Dallas Texas Not Yet Recruiting
Pediatric Dermatology of North Texas Grapevine Texas Recruiting
Texas Dermatology and Laser Specialists San Antonio Texas Recruiting

+ 87 more sites — see the full list on the official registry below.

On this site

📄 Olumiant (baricitinib) drug profile →

More Eli Lilly and Company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05723198 on ClinicalTrials.gov ↗ ← All trials in the USA