BRAVE-AA-PEDS: A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
Study Details
Study Description
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 |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Baricitinib High Dose Participants will receive baricitinib high dose orally. |
Drug: Baricitinib
Administered orally
Other Names:
|
| Experimental: Baricitinib Low Dose Participants will receive baricitinib low dose orally. |
Drug: Baricitinib
Administered orally
Other Names:
|
| Placebo Comparator: Placebo Participants will receive placebo |
Drug: Placebo
Administered orally
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20 [Week 36]
Secondary Outcome Measures
- Percent Change From Baseline in SALT Score [Baseline, Week 36]
- Percentage of Participants Achieving At Least 90% Improvement from Baseline (SALT90) [Week 36]
- Percentage of Participants Achieving an Absolute SALT ≤10 [Week 36]
- Percentage of Participants with Patient Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 [Week 36]
- Mean Change From Baseline in SALT Score [Baseline, Week 36]
- Percentage of Participants Achieving At Least 50% Improvement from Baseline (SALT50) [Week 36]
- Percentage of Participants Achieving At Least 75% Improvement from Baseline (SALT75) [Week 36]
- Percentage of Participants Achieving At Least 100% Improvement from Baseline (SALT100) [Week 36]
- 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 [Week 36]
- 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 [Week 36]
- Percentage of Participants Achieving PRO Measure for EB 0 or 1 (Among Participants with PRO Measure for EB ≥2 at Baseline) [Week 36]
- Percentage of Participants Achieving PRO Measure for EL 0 or 1 (Among Participants with PRO Measure for EL ≥2 at Baseline) [Week 36]
- Mean Change from Baseline in Hospital Anxiety Depression Scale (HADS) [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.
- Mean Change from Baseline in Patient-Reported Outcome Measurement Information System (PROMIS) Anxiety Score [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.
- Mean Change from Baseline in PROMIS Depression Score [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.
- Mean Change from Baseline in PROMIS Peer Relationship Score [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 (ages 8 to <18 years).
- Mean Change from Baseline in Family Dermatology Life Quality Index (FLDQI) [Baseline, Week 36]
The FLDQI 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.
- Pharmacokinetics (PK): Maximum Concentration (Cmax) [Baseline through Week 36]
- PK: Area Under the Concentration Curve (AUC) [Baseline through Week 36]
- Change of Immunoglobulin G (IgG) Titers [Pre-Vaccination to 4 Weeks and 12 Weeks Post-Vaccination]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have severe areata alopecia (AA) for at least 1 year
-
Current AA episode of at least 6 months' duration with hair loss encompassing ≥50% of the scalp
-
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.
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Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden
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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
Locations
No locations specified.Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16875
- I4V-MC-JAIO
- 2022-502700-78-00