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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03899259
Registration number
NCT03899259
Ethics application status
Date submitted
1/04/2019
Date registered
2/04/2019
Date last updated
14/05/2024
Titles & IDs
Public title
A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
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Scientific title
A Multicenter, Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata
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Secondary ID [1]
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I4V-MC-JAIR
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Secondary ID [2]
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16978
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Universal Trial Number (UTN)
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Trial acronym
BRAVE-AA2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alopecia Areata
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Condition category
Condition code
Inflammatory and Immune System
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Autoimmune diseases
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Skin
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0
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Baricitinib
Treatment: Drugs - Placebo
Experimental: 4 Milligram (mg) Baricitinib - Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.
Experimental: 2 mg Baricitinib - Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.
Placebo Comparator: Placebo - Participants received two placebo tablets administered orally QD to maintain the blind.
Experimental: 4 mg Baricitinib Maximum Extended Enrollment (MEE) - Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.
Experimental: 2 mg Baricitinib MEE - Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.
Placebo Comparator: Placebo MEE - Participants received two placebo tablets administered orally QD to maintain the blind.
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 Severity of Alopecia Tool (SALT) = 20
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Assessment method [1]
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The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes.
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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 at Week 36
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Assessment method [1]
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SALT uses a visual aid showing the division of the scalp hair into4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes. Least Squares Mean (LSM) was calculated using analysis of covariance (ANCOVA) with geographic region duration of current episode at baseline (< 4 years versus =4 years), treatment group, and baseline value in the model.
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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 50% Improvement of Severity of Alopecia Tool (SALT50)
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Assessment method [2]
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SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes. SALT50 indicates at least a 50 % improvement from baseline in the SALT score.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Percentage of Participants With Patient-Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 With a =2-point Improvement From Baseline Among Participants With a Score of =3 at Baseline
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Assessment method [3]
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PRO is an assessment of the particpant's current extent of scalp involvement. It is comprised of 5 category response options: 0= No missing hair (0% of my scalp is missing hair; I have a full head of hair); 1 = A limited area (1% to 20% of my scalp is missing hair); 2 = A moderate area (21% to 49% of my scalp is missing hair); 3 = A large area (50% to 94% of my scalp is missing hair); and 4 = Nearly all or all (95% to 100% of my scalp is missing hair).
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Timepoint [3]
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Week 36
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Secondary outcome [4]
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Time for Participants to Achieve SALT = 20
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Assessment method [4]
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Time for participants to achieve SALT = 20
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Timepoint [4]
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Week 52
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Secondary outcome [5]
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Percentage of Participants Achieving Clinician-Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 With =2-point Improvement From Baseline (Among Participants With ClinRO Measure for EB Hair Loss =2 at Baseline)
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Assessment method [5]
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ClinRO is a clinician reported assessment which measures a participant's EB hair loss. It is comprised of 4 category response options: 0 = EB have full coverage and no areas of hair loss; 1 = There are minimal gaps in EB hair and distribution is even; 2 = There are significant gaps in EB hair or distribution is not even; 3 = No notable EB.
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Timepoint [5]
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Week 36
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Secondary outcome [6]
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Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 With =2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss =2 at Baseline)
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Assessment method [6]
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ClinRO measure for EL hair loss is comprised of 4 category response options: 0 = The EL form a continuous line along the eyelids on both eyes; 1 = There are minimal gaps and the EL are evenly spaced along the eyelids on both eyes; 2 = There are significant gaps along the eyelids or the EL are not evenly spaced along the eyelids; 3 = No notable EL.
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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 Patient-Reported Outcome (PRO) Measure for EB 0 or 1 With =2-point Improvement From Baseline (Among Participants With PRO Measure for EB =2 at Baseline)
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Assessment method [7]
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PRO is an assessment of the participant's current appearance of eyebrows. It is comprised of 4 category response options: 0 = I have full EB on each eye; 1= I have a minimal gap(s) or a minimal amount of thinning in at least 1 of my EB; 2 = I have a large gap(s) or a large amount of thinning in at least 1 of my EB; and 3 = I have no or barely any EB hairs.
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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 PRO Measure for EL 0 or 1 With =2-point Improvement From Baseline (Among Participants With PRO Measure EL =2 at Baseline)
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Assessment method [8]
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PRO assessment of the participant's current appearance of EL. It is comprised of 4 category response options: 0 = I have full EL on each eyelid; 1 = I have a minimal gap or minimal gaps along the eyelids; 2 = I have a large gap or large gaps along the eyelids; and 3 = I have no or barely any EL hair.
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Timepoint [8]
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Week 36
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Secondary outcome [9]
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Change From Baseline in Skindex-16 Alopecia Areata (AA) Symptoms Domain Score
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Assessment method [9]
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Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life.
LS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (<4 years vs. = 4years), treatment group, and baseline value as fixed factors.
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Timepoint [9]
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Baseline, Week 36
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Secondary outcome [10]
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Change From Baseline in Skindex-16 AA Emotions Domain Score at Week 36
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Assessment method [10]
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Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life.
LS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (<4 years vs. = 4years), treatment group, and baseline value as fixed factors.
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Timepoint [10]
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Baseline, Week 36
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Secondary outcome [11]
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Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36
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Assessment method [11]
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Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life.
LS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (<4 years vs. = 4years), treatment group, and baseline value as fixed factors.
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Timepoint [11]
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Baseline, Week 36
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Secondary outcome [12]
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Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score at Week 36
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Assessment method [12]
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The HADS is a 14-item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (for example, 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression.
LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (<4 years vs. =4 years), treatment group and baseline score as fixed factors.
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Timepoint [12]
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Baseline, Week 36
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Secondary outcome [13]
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Mean Change From Baseline in HADS Depression Score at Week 36
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Assessment method [13]
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The HADS is a 14-item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (for example, 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression.
LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (<4 years vs. =4 years), treatment group and baseline score as fixed factors.
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Timepoint [13]
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Baseline,Week 36
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Eligibility
Key inclusion criteria
- Are at least 18 years and =60 years for males (=70 years of age for females) at the
time of informed consent.
- Have severe or very severe AA, as determined by all of the following:
- Current AA episode of more than 6 months' duration and hair loss encompassing
=50% of the scalp, as measured by SALT (AA-IGA of 3 or 4) at screening and
baseline.
- No spontaneous improvement over the past 6 months.
- Current episode of severe or very severe AA of less than 8 years. Note:
participants who have severe or very 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.
- Male or nonpregnant, nonbreastfeeding female participants.
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Minimum age
18
Years
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Maximum age
70
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.
- Are currently experiencing other forms of alopecia or any other concomitant conditions
that would interfere with evaluations of the effect of study medication on AA.
- Previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequate
response (for example, absence of significant terminal hair growth after at least 12
weeks of treatment).
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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
Active, not 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
8/07/2019
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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
29/07/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
546
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Woden Dermatology - Phillip
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Recruitment hospital [2]
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Skin & Cancer Foundation Australia - Westmead
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Recruitment hospital [3]
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Veracity Clinical Research Pty Ltd - Woolloongabba
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Recruitment hospital [4]
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Clinical Trials SA Pty Ltd - Adelaide
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Recruitment hospital [5]
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Skin Health Institute Inc. - Carlton
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Fremantle Dermatology - Perth
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Recruitment hospital [7]
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Sinclair Dermatology - Victoria
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Recruitment postcode(s) [1]
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2606 - Phillip
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Recruitment postcode(s) [2]
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2045 - Westmead
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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5073 - Adelaide
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Recruitment postcode(s) [5]
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3053 - Carlton
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Recruitment postcode(s) [6]
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6160 - Perth
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Recruitment postcode(s) [7]
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3002 - Victoria
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Recruitment outside Australia
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United States of America
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Alabama
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Ciudad Autónoma De Buenos Aires
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Tucuman
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Mendoza
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China
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Shan XI
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China
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China
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Zhejiang
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China
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Tianjin
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Israel
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Afula
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Japan
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Kanagawa
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Japan
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Japan
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Yamaguchi
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Japan
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Osaka
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Korea, Republic of
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Chungcheongnam-do
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Gyeonggi-do
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Seoul-teukbyeolsi [Seoul]
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Seoul
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San Juan
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Taichung City (r.o.c)
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Taiwan
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Tainan
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Taiwan
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Taipei City
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Taiwan
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Taoyuan
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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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Other collaborator category [1]
0
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Commercial sector/Industry
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Name [1]
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Incyte Corporation
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Address [1]
0
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Ethics approval
Ethics application status
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Summary
Brief summary
The reason for this study is to see if baricitinib is safe and effective in adults with
severe or very severe alopecia areata (AA).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03899259
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Contact person for public queries
Name
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03899259
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