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NCT Number: NCT05723198

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

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.

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Key information

Conditions

Areata Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Derma Internacional SA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Baricitinib

Drug

Administered orally

Other names: LY3009104

Placebo

Drug

Administered orally

Primary outcomes

  1. Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20

    Time frame: Week 36

Secondary outcomes

  1. Percent Change from Baseline in SALT Score

    Time frame: Baseline, Week 36

  2. Percentage of Participants Achieving At Least 90% Improvement from Baseline (SALT90)

    Time frame: Week 36

  3. Percentage of Participants Achieving an Absolute SALT ≤10

    Time frame: Week 36

  4. Percentage of Participants with Patient Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 Among Participants 12 Years and Older with PRO for Scalp Hair Assessment Score ≥3 at Baseline

    Time frame: Week 36

  5. Mean Change from Baseline in SALT Score

    Time frame: Baseline, Week 36

  6. Percentage of Participants Achieving At Least 50% Improvement from Baseline (SALT50)

    Time frame: Week 36

  7. Percentage of Participants Achieving At Least 75% Improvement from Baseline (SALT75)

    Time frame: Week 36

  8. Percentage of Participants Achieving At Least 100% Improvement from Baseline (SALT100)

    Time frame: Week 36

  9. Percentage of Participants Achieving Clinician-Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 Among Participants with CLinRO Measure for EB Hair Loss ≥2 at Baseline

    Time frame: Week 36

  10. Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 Among Participants with CLinRO Measure for EL Hair Loss ≥2 at Baseline

    Time frame: Week 36

  11. Percentage of Participants Achieving PRO Measure for EB 0 or 1 (Among Participants 12 Years or Older with PRO Measure for EB ≥2 at Baseline)

    Time frame: Week 36

  12. Percentage of Participants Achieving PRO Measure for EL 0 or 1 (Among Participants 12 Years or Older with PRO Measure for EL ≥2 at Baseline)

    Time frame: Week 36

  13. Mean Change from Baseline in Hospital Anxiety Depression Scale (HADS)

    Time frame: Week 36

    The HADS is a participant-rated instrument used to assess both anxiety and depression and is available in a pediatric self-report for participants ≥12 years old. This instrument consists of 14 item questionnaires, each item is rated on a 4-point scale. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression.

  14. Mean Change from Baseline in Patient-Reported Outcome Measurement Information System (PROMIS) Anxiety Score

    Time frame: Baseline, Week 36

    The PROMIS Anxiety Short Form (8 questions, 8a v2.0) is available in a pediatric self-report (ages 8 to <18 years) and for parents/caregivers serving as proxy reporters for their children (youth ages ≥5 years). Both pediatric self-report and proxy-report versions assess anxiety "in the past seven days". Response options range from 1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; to 5 = Almost always. Total raw scores are converted to T-Scores with higher scores representing greater anxiety.

  15. Mean Change from Baseline in PROMIS Depression Score

    Time frame: Baseline, Week 36

    The PROMIS Depression Short Form (8a v2.0 and 6a v2.0) is available in a pediatric self-report (ages 8 to <18 years) and for parents/caregivers serving as proxy reporters for their children (youth ages ≥5 years). Both pediatric self-report and proxy-report versions assess depression "in the past seven days." Response options range from 1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; to 5 = Almost always. Total raw scores are converted to T-Scores with higher scores representing greater depression.

  16. Mean Change from Baseline in PROMIS Peer Relationship Score

    Time frame: Baseline, Week 36

    The PROMIS Peer Relationships Short Form planned to be used in the study measures 2 aspects of social functioning, friendship quality and peer acceptance, and is available in a pediatric self-report (ages 8 to <18 years) and for parents/caregivers serving as proxy reporters for their children (youth ages 5 to <8 years).

  17. Mean Change from Baseline in Family Dermatology Life Quality Index (FDLQI)

    Time frame: Baseline, Week 36

    The FDLQI is a 10-item validated questionnaire designed for adult (>16 years old) family members of participants. The questionnaire is completed by family members of the AA participants (for example, parents/caregivers) and measures the secondary impact of the participant's skin disease on family QoL. Response categories include "not at all/not relevant," "only a little," "quite a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively, with unanswered ("not relevant") responses scored as 0.

  18. Pharmacokinetics (PK): Maximum Concentration (Cmax)

    Time frame: Baseline through Week 36

  19. PK: Area Under the Concentration Curve (AUC)

    Time frame: Baseline through Week 36

  20. Change of Immunoglobulin G (IgG) Titers

    Time frame: Pre-Vaccination to 4 Weeks and 12 Weeks Post-Vaccination

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

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

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Acronym: BRAVE-AA-PEDS

Important dates

Study start
2023
Primary completion
2028
Study completion
2033
First posted
Feb 10, 2023
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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