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

RecruitingPhase 3

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

Who can join

Ages 6 to 17 · All sexes

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: Eli Lilly and Company · Participants: 595 · Started: Feb 27, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05723198

Locations in the U.S.

AlabamaTotal Skin and Beauty Dermatology Center, PC, Birmingham
University of Alabama at Birmingham, Birmingham (Not yet recruiting)
ArizonaInvestigate MD, Scottsdale
CaliforniaCalifornia Dermatology & Clinical Research Institute, Encinitas (Not yet recruiting)
Dermatology Research Associates, Los Angeles
University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology, San Diego
The Permanente Medical Group, Inc., San Francisco
Southern California Dermatology, Inc., Santa Ana
ConnecticutDermatology Physicians of Connecticut, Fairfield (Not yet recruiting)
FloridaSkin Care Research, Inc, Boca Raton (Not yet recruiting)
D&H Doral Research Center LLC, Doral (Not yet recruiting)
Skin Care Research, Inc, Hollywood (Not yet recruiting)
Solutions Through Advanced Research, Inc., Jacksonville
Pediatric Skin Research, LLC, Miami
University of Miami Miller School of Medicine, Miami (Not yet recruiting)
GeorgiaSkin Care Physicians of Georgia, Macon
IllinoisNorthwestern University, Chicago (Not yet recruiting)
Northshore University Healthsystem, Skokie
IndianaDawes Fretzin Clinical Research Group, LLC, Indianapolis
The South Bend Clinic Center for Research, South Bend
MarylandDermAssociates PC., Rockville
MichiganMichigan Center for Research Company, Clarkston
MinnesotaUniversity of Minnesota Medical School, Minneapolis
MissouriMediSearch Clinical Trials, Saint Joseph
NebraskaAdvanced Skin Research Center, Omaha
New YorkMontefiore Medical Center, The Bronx
North CarolinaDermatology Specialists of Charlotte, Charlotte
OhioBexley Dermatology Research, Bexley
Cincinnati Childrens Hospital Medical Center, Cincinnati (Not yet recruiting)
University Hospitals Cleveland Medical Center, Cleveland (Not yet recruiting)
OklahomaVital Prospects Clinical Research Institute, P.C., Tulsa
OregonNorthwest Dermatology Institute, Portland
South CarolinaMedical University of South Carolina, Charleston
TennesseeInternational Clinical Research - Tennessee (IC Research), Murfreesboro
TexasDermatology Treatment and Research Center, Dallas (Not yet recruiting)
Pediatric Dermatology of North Texas, Grapevine
Texas Dermatology and Laser Specialists, San Antonio
Complete Dermatology, Sugar Land
UtahUniversity of Utah MidValley Dematology, Murray (Not yet recruiting)
VirginiaVirginia Clinical Research, Norfolk
WisconsinUniversity of Wisconsin-Madison, Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.