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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
Date last updated
19/07/2024
Titles & IDs
Public title
A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
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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
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Secondary ID [1]
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I4V-MC-JAIO
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Secondary ID [2]
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16875
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Universal Trial Number (UTN)
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Trial acronym
BRAVE-AA-PEDS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) =20
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Assessment method [1]
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Timepoint [1]
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Week 36
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Secondary outcome [1]
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Percent Change from Baseline in SALT Score
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Assessment method [1]
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Timepoint [1]
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Baseline, Week 36
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Secondary outcome [2]
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Percentage of Participants Achieving At Least 90% Improvement from Baseline (SALT90)
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Assessment method [2]
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Timepoint [2]
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Week 36
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Secondary outcome [3]
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Percentage of Participants Achieving an Absolute SALT =10
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Assessment method [3]
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Timepoint [3]
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Week 36
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Secondary outcome [4]
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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
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Assessment method [4]
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Timepoint [4]
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Week 36
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Secondary outcome [5]
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Mean Change from Baseline in SALT Score
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Assessment method [5]
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Timepoint [5]
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Baseline, Week 36
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Secondary outcome [6]
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Percentage of Participants Achieving At Least 50% Improvement from Baseline (SALT50)
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Assessment method [6]
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Timepoint [6]
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Week 36
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Secondary outcome [7]
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Percentage of Participants Achieving At Least 75% Improvement from Baseline (SALT75)
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Assessment method [7]
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Timepoint [7]
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Week 36
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Secondary outcome [8]
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Percentage of Participants Achieving At Least 100% Improvement from Baseline (SALT100)
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Assessment method [8]
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Timepoint [8]
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Week 36
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Secondary outcome [9]
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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
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Assessment method [9]
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Timepoint [9]
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Week 36
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Secondary outcome [10]
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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
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Assessment method [10]
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Timepoint [10]
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Week 36
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Secondary outcome [11]
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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)
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Assessment method [11]
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Timepoint [11]
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Week 36
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Secondary outcome [12]
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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)
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Assessment method [12]
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Timepoint [12]
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Week 36
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Secondary outcome [13]
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Mean Change from Baseline in Hospital Anxiety Depression Scale (HADS)
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Assessment method [13]
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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.
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Timepoint [13]
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Week 36
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Secondary outcome [14]
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Mean Change from Baseline in Patient-Reported Outcome Measurement Information System (PROMIS) Anxiety Score
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Assessment method [14]
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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.
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Timepoint [14]
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Baseline, Week 36
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Secondary outcome [15]
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Mean Change from Baseline in PROMIS Depression Score
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Assessment method [15]
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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.
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Timepoint [15]
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Baseline, Week 36
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Secondary outcome [16]
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Mean Change from Baseline in PROMIS Peer Relationship Score
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Assessment method [16]
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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).
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Timepoint [16]
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Baseline, Week 36
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Secondary outcome [17]
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Mean Change from Baseline in Family Dermatology Life Quality Index (FDLQI)
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Assessment method [17]
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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.
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Timepoint [17]
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Baseline, Week 36
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Secondary outcome [18]
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Pharmacokinetics (PK): Maximum Concentration (Cmax)
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Assessment method [18]
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Timepoint [18]
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Baseline through Week 36
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Secondary outcome [19]
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PK: Area Under the Concentration Curve (AUC)
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Assessment method [19]
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Timepoint [19]
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Baseline through Week 36
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Secondary outcome [20]
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Change of Immunoglobulin G (IgG) Titers
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Assessment method [20]
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Timepoint [20]
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Pre-Vaccination to 4 Weeks and 12 Weeks Post-Vaccination
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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.
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Minimum age
6
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/02/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2029
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Actual
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Sample size
Target
595
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Arizona
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California
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Connecticut
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Florida
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United States of America
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Georgia
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Illinois
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Indiana
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Maryland
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Michigan
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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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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05723198
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Contact person for public queries
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There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
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Address
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Phone
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-317-615-4559
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
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
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