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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05723198




Registration number
NCT05723198
Ethics application status
Date submitted
3/02/2023
Date registered
10/02/2023

Titles & IDs
Public title
A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
Scientific 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
Secondary ID [1] 0 0
I4V-MC-JAIO
Secondary ID [2] 0 0
16875
Universal Trial Number (UTN)
Trial acronym
BRAVE-AA-PEDS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Areata Alopecia 0 0
Alopecia 0 0
Hypotrichosis 0 0
Hair Diseases 0 0
Skin Diseases 0 0
Pathological Conditions, Anatomical 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Other skin conditions
Skin 0 0 0 0
Dermatological conditions
Public Health 0 0 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Baricitinib
Treatment: Drugs - Placebo

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


Treatment: Drugs: Baricitinib
Administered orally

Treatment: Drugs: Placebo
Administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) =20
Timepoint [1] 0 0
Week 36
Secondary outcome [1] 0 0
Percent Change from Baseline in SALT Score
Timepoint [1] 0 0
Baseline, Week 36
Secondary outcome [2] 0 0
Percentage of Participants Achieving At Least 90% Improvement from Baseline (SALT90)
Timepoint [2] 0 0
Week 36
Secondary outcome [3] 0 0
Percentage of Participants Achieving an Absolute SALT =10
Timepoint [3] 0 0
Week 36
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Week 36
Secondary outcome [5] 0 0
Mean Change from Baseline in SALT Score
Timepoint [5] 0 0
Baseline, Week 36
Secondary outcome [6] 0 0
Percentage of Participants Achieving At Least 50% Improvement from Baseline (SALT50)
Timepoint [6] 0 0
Week 36
Secondary outcome [7] 0 0
Percentage of Participants Achieving At Least 75% Improvement from Baseline (SALT75)
Timepoint [7] 0 0
Week 36
Secondary outcome [8] 0 0
Percentage of Participants Achieving At Least 100% Improvement from Baseline (SALT100)
Timepoint [8] 0 0
Week 36
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Week 36
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Week 36
Secondary outcome [11] 0 0
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)
Timepoint [11] 0 0
Week 36
Secondary outcome [12] 0 0
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)
Timepoint [12] 0 0
Week 36
Secondary outcome [13] 0 0
Mean Change from Baseline in Hospital Anxiety Depression Scale (HADS)
Timepoint [13] 0 0
Week 36
Secondary outcome [14] 0 0
Mean Change from Baseline in Patient-Reported Outcome Measurement Information System (PROMIS) Anxiety Score
Timepoint [14] 0 0
Baseline, Week 36
Secondary outcome [15] 0 0
Mean Change from Baseline in PROMIS Depression Score
Timepoint [15] 0 0
Baseline, Week 36
Secondary outcome [16] 0 0
Mean Change from Baseline in PROMIS Peer Relationship Score
Timepoint [16] 0 0
Baseline, Week 36
Secondary outcome [17] 0 0
Mean Change from Baseline in Family Dermatology Life Quality Index (FDLQI)
Timepoint [17] 0 0
Baseline, Week 36
Secondary outcome [18] 0 0
Pharmacokinetics (PK): Maximum Concentration (Cmax)
Timepoint [18] 0 0
Baseline through Week 36
Secondary outcome [19] 0 0
PK: Area Under the Concentration Curve (AUC)
Timepoint [19] 0 0
Baseline through Week 36
Secondary outcome [20] 0 0
Change of Immunoglobulin G (IgG) Titers
Timepoint [20] 0 0
Pre-Vaccination to 4 Weeks and 12 Weeks Post-Vaccination

Eligibility
Key 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.
Minimum age
6 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2029
Actual
Sample size
Target
595
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Skin and Cancer Foundation Australia - Darlinghurst Clinic - Darlinghurst
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment hospital [4] 0 0
Sinclair Dermatology - Melbourne
Recruitment hospital [5] 0 0
Institute for Skin, Health, and Immunity - Mitcham
Recruitment postcode(s) [1] 0 0
02010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3002 - Melbourne
Recruitment postcode(s) [5] 0 0
3132 - Mitcham
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Maryland
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Michigan
Country [11] 0 0
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Minnesota
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Missouri
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Nebraska
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New York
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North Carolina
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Slaskie
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Alicante
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Badalona
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Bilbao
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Madrid
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Pamplona
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Spain
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Pozuelo de Alarcon
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Spain
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Valencia
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Taiwan
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New Taipei
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taipei
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Taiwan
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Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
-317-615-4559
Fax 0 0
Email 0 0
ClinicalTrials.gov@lilly.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05723198