Recruiting

Phase 3

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

Sponsor:

Eli Lilly and Company

Code:

NCT05723198

Conditions

Areata Alopecia

Alopecia

Hypotrichosis

Hair Diseases

Skin Diseases

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Baricitinib

Placebo

Study Details

Brief 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.

Conditions

Areata Alopecia

Alopecia

Hypotrichosis

Hair Diseases

Skin Diseases

Study ID

NCT05723198

Start date

Feb 27, 2023

Status verified date

Jul, 2026

Completion date

Sep, 2033

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

595 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Baricitinib High Dose

Participants will receive baricitinib high dose orally.

experimental: Baricitinib Low Dose

Participants will receive baricitinib low dose orally.

placebo comparator: Placebo

Participants will receive placebo

Interventions

Baricitinib

Administered orally

Placebo

Administered orally

Primary outcome measure

Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20 [ Time Frame: Week 36 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Total Skin and Beauty Dermatology Center, PC

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

205-380-6148

Principal Investigator:

James Krell

Investigate MD

Recruiting

Scottsdale, Arizona, United States, 85255

Contacts

480-440-5985

Principal Investigator:

Brenda LaTowsky

Dermatology Research Associates

Recruiting

Los Angeles, California, United States, 90045

Contacts

310-337-7171

Principal Investigator:

Howard Sofen

University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology

Recruiting

San Diego, California, United States, 92123

Contacts

858-966-1700 ext. 224295

Principal Investigator:

Dawn Eichenfield

The Permanente Medical Group, Inc.

Recruiting

San Francisco, California, United States, 94118

Contacts

707-651-1000

Principal Investigator:

Paradi Mirmirani

Southern California Dermatology, Inc.

Recruiting

Santa Ana, California, United States, 92701

Contacts

714-547-5151

Principal Investigator:

Jennifer Soung

Solutions Through Advanced Research, Inc.

Recruiting

Jacksonville, Florida, United States, 32256

Contacts

904-619-8157

Principal Investigator:

Pearl Kwong

Pediatric Skin Research, LLC

Recruiting

Miami, Florida, United States, 33156

Contacts

786-585-5774

Principal Investigator:

Mercedes Gonzalez

Skin Care Physicians of Georgia

Recruiting

Macon, Georgia, United States, 31217

Contacts

478-742-2180 ext 255

Principal Investigator:

David Cohen

Northshore University Healthsystem

Recruiting

Skokie, Illinois, United States, 60077

Contacts

847-663-8530

Principal Investigator:

Joel Joyce

Dawes Fretzin Clinical Research Group, LLC

Recruiting

Indianapolis, Indiana, United States, 46250

Contacts

317-516-5030 ext 115

Principal Investigator:

Kenneth Dawes

The South Bend Clinic Center for Research

Recruiting

South Bend, Indiana, United States, 46617

Contacts

574-204-6192

Principal Investigator:

Holly Hake Harris

DermAssociates PC.

Recruiting

Rockville, Maryland, United States, 20850

Contacts

301-355-3183

Principal Investigator:

Benjamin Lockshin

Michigan Center for Research Company

Recruiting

Clarkston, Michigan, United States, 48346

Contacts

248-620-3376

Principal Investigator:

Wendy McFalda

University of Minnesota Medical School

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

612-625-8625

Principal Investigator:

Maria Hordinsky

MediSearch Clinical Trials

Recruiting

Saint Joseph, Missouri, United States, 64506

Contacts

816-364-1515

Principal Investigator:

MELODY STONE

Advanced Skin Research Center

Recruiting

Omaha, Nebraska, United States, 68144

Contacts

402-697-6599

Principal Investigator:

Joel Schlessinger

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

718-920-8352

Principal Investigator:

Holly Kanavy

Dermatology Specialists of Charlotte

Recruiting

Charlotte, North Carolina, United States, 28277

Contacts

7042479179 x212

Principal Investigator:

Deborah Nixon

Bexley Dermatology Research

Recruiting

Bexley, Ohio, United States, 43209

Contacts

614-725-5010

Principal Investigator:

Matthew Zirwas

Vital Prospects Clinical Research Institute, P.C.

Recruiting

Tulsa, Oklahoma, United States, 74136

Contacts

918-392-4550

Principal Investigator:

Iftikhar Hussain

Northwest Dermatology Institute

Recruiting

Portland, Oregon, United States, 97210

Contacts

503-223-1933

Principal Investigator:

Nisha Desai

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

843-792-3021

Principal Investigator:

Lara Wine Lee

International Clinical Research - Tennessee (IC Research)

Recruiting

Murfreesboro, Tennessee, United States, 37130

Contacts

615-410-3460

Principal Investigator:

Christina Feser

Pediatric Dermatology of North Texas

Recruiting

Grapevine, Texas, United States, 76051

Contacts

972-354-1520

Principal Investigator:

Fred Ghali

Texas Dermatology and Laser Specialists

Recruiting

San Antonio, Texas, United States, 78218

Contacts

(210) 852-2779 Ext. 1004

Principal Investigator:

John Browning

Complete Dermatology

Recruiting

Sugar Land, Texas, United States, 77479

Contacts

281-240-4313

Principal Investigator:

Vandana Madkan

Virginia Clinical Research

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

757-625-0151

Principal Investigator:

David Pariser

University of Wisconsin-Madison

Recruiting

Madison, Wisconsin, United States, 53715

Contacts

608-287-2450

Principal Investigator:

Lisa Arkin

Dermatology Research Institute

Recruiting

Calgary, Canada, T2J 7E1

Contacts

4032633376

Principal Investigator:

Vimal Prajapati

Skin Health

Recruiting

Cobourg, Canada, K9A 0Z4

Contacts

(289) 252-1856

Principal Investigator:

Melinda Gooderham

Lynderm Research Inc.

Recruiting

Markham, Canada, L3P 1X2

Contacts

905-471-8011

Principal Investigator:

Charles Lynde

Dr. Chih-ho Hong Medical Inc.

Recruiting

Surrey, Canada, V3R 6A7

Contacts

604-953-1333

Principal Investigator:

Gurbir Dhadwal

Research Toronto

Recruiting

Toronto, Canada, M4W 2N2

Contacts

416-962-0123

Principal Investigator:

Sameh Hanna

Wiseman Dermatology Research Inc.

Recruiting

Winnipeg, Canada, R3M 3Z4

Contacts

204-943-4922

Principal Investigator:

Marni Wiseman

More Information

Sponsor

Eli Lilly and Company

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-07-17.