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

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ClinicalTrials.gov Identifier: NCT05723198
Recruitment Status : Recruiting
First Posted : February 10, 2023
Last Update Posted : May 17, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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 Period, and a 4-week Post-treatment Follow-up period.


Condition or disease Intervention/treatment Phase
Areata Alopecia Alopecia Hypotrichosis Hair Diseases Skin Diseases Pathological Conditions, Anatomical Drug: Baricitinib Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 595 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : February 27, 2023
Estimated Primary Completion Date : November 6, 2024
Estimated Study Completion Date : August 10, 2029

Resource links provided by the National Library of Medicine

Drug Information available for: Baricitinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Baricitinib High Dose
Participants will receive baricitinib high dose orally.
 Drug: Baricitinib
Administered orally
Other Name: LY3009104
Experimental: Baricitinib Low Dose
Participants will receive baricitinib low dose orally.
 Drug: Baricitinib
Administered orally
Other Name: LY3009104
Placebo Comparator: Placebo
Participants will receive placebo
 Drug: Placebo
Administered orally


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

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05723198


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or -317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05723198    
Other Study ID Numbers: 16875
I4V-MC-JAIO ( Other Identifier: Eli Lilly and Company )
2022-502700-78-00 ( Other Identifier: EU Trial Number )
First Posted: February 10, 2023    Key Record Dates
Last Update Posted: May 17, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Skin Diseases
 Hypotrichosis
Hair Diseases
Pathological Conditions, Anatomical