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Bored Studies
RecruitingPhase 3

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

Eli Lilly and Company · NCT05723198

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6–17 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
595
US sites recruiting
29
Study start
February 27, 2023
Record last updated
September 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Baricitinib; Placebo

Conditions: Areata Alopecia; Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Total Skin and Beauty Dermatology Center, PC

    Birmingham, AL 35205

    Site contact: 205-380-6148

  • Investigate MD

    Scottsdale, AZ 85255

    Site contact: 480-440-5985

  • Dermatology Research Associates

    Los Angeles, CA 90045

    Site contact: 310-337-7171

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

    San Diego, CA 92123

    Site contact: 858-966-1700 ext. 224295

  • The Permanente Medical Group, Inc.

    San Francisco, CA 94118

    Site contact: 707-651-1000

  • Southern California Dermatology, Inc.

    Santa Ana, CA 92701

    Site contact: 714-547-5151

  • Solutions Through Advanced Research, Inc.

    Jacksonville, FL 32256

    Site contact: 904-619-8157

  • Pediatric Skin Research, LLC

    Miami, FL 33156

    Site contact: 786-585-5774

  • Skin Care Physicians of Georgia

    Macon, GA 31217

    Site contact: 478-742-2180 ext 255

  • Northshore University Healthsystem

    Skokie, IL 60077

    Site contact: 847-663-8530

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, IN 46250

    Site contact: 317-516-5030 ext 115

  • The South Bend Clinic Center for Research

    South Bend, IN 46617

    Site contact: 574-204-6192

  • DermAssociates PC.

    Rockville, MD 20850

    Site contact: 301-355-3183

  • Michigan Center for Research Company

    Clarkston, MI 48346

    Site contact: 248-620-3376

  • University of Minnesota Medical School

    Minneapolis, MN 55455

    Site contact: 612-625-8625

  • MediSearch Clinical Trials

    Saint Joseph, MO 64506

    Site contact: 816-364-1515

  • Advanced Skin Research Center

    Omaha, NE 68144

    Site contact: 402-697-6599

  • Montefiore Medical Center

    The Bronx, NY 10467

    Site contact: 718-920-8352

  • Dermatology Specialists of Charlotte

    Charlotte, NC 28277

    Site contact: 7042479179 x212

  • Bexley Dermatology Research

    Bexley, OH 43209

    Site contact: 614-725-5010

  • Vital Prospects Clinical Research Institute, P.C.

    Tulsa, OK 74136

    Site contact: 918-392-4550

  • Northwest Dermatology Institute

    Portland, OR 97210

    Site contact: 503-223-1933

  • Medical University of South Carolina

    Charleston, SC 29425

    Site contact: 843-792-3021

  • International Clinical Research - Tennessee (IC Research)

    Murfreesboro, TN 37130

    Site contact: 615-410-3460

  • Pediatric Dermatology of North Texas

    Grapevine, TX 76051

    Site contact: 972-354-1520

  • Texas Dermatology and Laser Specialists

    San Antonio, TX 78218

    Site contact: (210) 852-2779 Ext. 1004

  • Complete Dermatology

    Sugar Land, TX 77479

    Site contact: 281-240-4313

  • Virginia Clinical Research

    Norfolk, VA 23502

    Site contact: 757-625-0151

  • University of Wisconsin-Madison

    Madison, WI 53715

    Site contact: 608-287-2450

Study contacts (from the official record)

  • 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
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