Alopecia Areata
Conditions
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).
Interventions
DRUGBaricitinib
Administered orally
DRUGPlacebo
Administered orally
Sponsors
Eli Lilly and Company
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 | Week 36 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in SALT Score at Week 36 | Baseline, Week 36 | 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. 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. |
| Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) | Week 12 | 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. |
| 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 | Week 36 | 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). |
| Time for Participants to Achieve SALT ≤ 20 at Week 36. | Week 36 | 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. Kaplan-Meier method was used for analysis. Time for participants to achieve salt ≤ 20 at week 36 were reported in this outcome measure. |
| 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) | Week 36 | 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. |
| 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) | Week 36 | 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. |
| 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) | Week 36 | 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. |
| 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) | Week 36 | 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. |
| Change From Baseline in Skindex-16 Alopecia Areata (AA) Symptoms Domain Score | Baseline, Week 36 | 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. |
| Change From Baseline in Skindex-16 AA Emotions Domain Score at Week 36 | Baseline, Week 36 | 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. |
| Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36 | Baseline, Week 36 | 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. |
| Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score at Week 36 | Baseline, Week 36 | 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. |
| Mean Change From Baseline in HADS Depression Score at Week 36 | Baseline,Week 36 | 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. |
Countries
Argentina, Australia, Brazil, China, Israel, Japan, Puerto Rico, South Korea, Taiwan, United States
Contacts
STUDY_DIRECTORCall 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
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received two placebo tablets administered orally QD to maintain the blind. | 156 |
| 2 mg Baricitinib Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.. | 156 |
| 4 mg Baricitinib Participants received one 4 mg Baricitinib administered orally every day (QD) and one placebo administered orally QD to maintain blind. | 234 |
| Total | 546 |
Baseline characteristics
| Characteristic | Placebo | Total | 4 mg Baricitinib | 2 mg Baricitinib |
|---|---|---|---|---|
| Age, Continuous | 36.0 years STANDARD_DEVIATION 12.24 | 37.2 years STANDARD_DEVIATION 12.55 | 37.2 years STANDARD_DEVIATION 12.47 | 38.2 years STANDARD_DEVIATION 12.96 |
| Baseline Disease Severity of Alopecia Tool (SALT) Score | 84.6 units on a scale STANDARD_DEVIATION 17.75 | 85.0 units on a scale STANDARD_DEVIATION 18 | 84.9 units on a scale STANDARD_DEVIATION 18.03 | 85.3 units on a scale STANDARD_DEVIATION 18.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 68 Participants | 227 Participants | 92 Participants | 67 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 46 Participants | 18 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 11 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 85 Participants | 321 Participants | 144 Participants | 92 Participants |
| Region of Enrollment Argentina | 15 Participants | 46 Participants | 20 Participants | 11 Participants |
| Region of Enrollment Australia | 17 Participants | 54 Participants | 20 Participants | 17 Participants |
| Region of Enrollment Brazil | 14 Participants | 51 Participants | 24 Participants | 13 Participants |
| Region of Enrollment China | 19 Participants | 70 Participants | 31 Participants | 20 Participants |
| Region of Enrollment Israel | 14 Participants | 58 Participants | 25 Participants | 19 Participants |
| Region of Enrollment Japan | 10 Participants | 41 Participants | 20 Participants | 11 Participants |
| Region of Enrollment South Korea | 23 Participants | 66 Participants | 26 Participants | 17 Participants |
| Region of Enrollment Taiwan | 7 Participants | 30 Participants | 11 Participants | 12 Participants |
| Region of Enrollment United States | 54 Participants | 190 Participants | 82 Participants | 54 Participants |
| Sex: Female, Male Female | 108 Participants | 380 Participants | 161 Participants | 111 Participants |
| Sex: Female, Male Male | 65 Participants | 226 Participants | 98 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 171 | 0 / 173 | 0 / 258 | 0 / 578 |
| other Total, other adverse events | 44 / 171 | 85 / 173 | 133 / 258 | 321 / 578 |
| serious Total, serious adverse events | 3 / 171 | 5 / 173 | 16 / 258 | 34 / 578 |
Outcome results
Primary
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20
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.
Time frame: Week 36
Population: All randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 | 2.6 percentage of participants |
| 2 mg Baricitinib | Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 | 17.3 percentage of participants |
| 4 mg Baricitinib | Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 | 32.5 percentage of participants |
p-value: <0.00195% CI: [2.79, 22.17]Regression, Logistic
p-value: <0.00195% CI: [7.3, 53.3]Regression, Logistic
Secondary
Change From Baseline in Skindex-16 AA Emotions Domain Score at Week 36
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.
Time frame: Baseline, Week 36
Population: All randomized participants with baseline and at least one postbaseline Skindex-16 AA emotions domain score. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Skindex-16 AA Emotions Domain Score at Week 36 | -11.98 score on a scale | Standard Error 2.154 |
| 2 mg Baricitinib | Change From Baseline in Skindex-16 AA Emotions Domain Score at Week 36 | -18.73 score on a scale | Standard Error 2.171 |
| 4 mg Baricitinib | Change From Baseline in Skindex-16 AA Emotions Domain Score at Week 36 | -25.40 score on a scale | Standard Error 1.732 |
p-value: 0.02695% CI: [-12.68, -0.82]ANCOVA
p-value: <0.00195% CI: [-18.8, -8.04]ANCOVA
Secondary
Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36
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.
Time frame: Baseline, Week 36
Population: All randomized participants with baseline and at least one postbaseline Skindex-16 AA functioning domain score. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36 | -9.67 score on a scale | Standard Error 1.913 |
| 2 mg Baricitinib | Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36 | -14.05 score on a scale | Standard Error 1.925 |
| 4 mg Baricitinib | Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36 | -18.00 score on a scale | Standard Error 1.535 |
p-value: 0.10395% CI: [-9.65, 0.88]ANCOVA
p-value: <0.00195% CI: [-13.1, -3.56]ANCOVA
Secondary
Change From Baseline in Skindex-16 Alopecia Areata (AA) Symptoms Domain Score
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.
Time frame: Baseline, Week 36
Population: All randomized participants with baseline and at least one postbaseline Skindex-16 AA Symptoms Domain Score. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Skindex-16 Alopecia Areata (AA) Symptoms Domain Score | 1.17 score on a scale | Standard Error 1.415 |
| 2 mg Baricitinib | Change From Baseline in Skindex-16 Alopecia Areata (AA) Symptoms Domain Score | -1.85 score on a scale | Standard Error 1.425 |
| 4 mg Baricitinib | Change From Baseline in Skindex-16 Alopecia Areata (AA) Symptoms Domain Score | -3.04 score on a scale | Standard Error 1.138 |
p-value: 0.12995% CI: [-6.91, 0.88]ANCOVA
p-value: 0.0295% CI: [-7.75, -0.68]ANCOVA
Secondary
Mean Change From Baseline in HADS Depression Score at Week 36
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.
Time frame: Baseline,Week 36
Population: All randomized participants with baseline and at least one postbaseline HADS depression score. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in HADS Depression Score at Week 36 | 0.29 score on a scale | Standard Error 0.208 |
| 2 mg Baricitinib | Mean Change From Baseline in HADS Depression Score at Week 36 | -0.22 score on a scale | Standard Error 0.21 |
| 4 mg Baricitinib | Mean Change From Baseline in HADS Depression Score at Week 36 | -0.39 score on a scale | Standard Error 0.167 |
p-value: 0.08395% CI: [-1.08, 0.07]ANCOVA
p-value: 0.0195% CI: [-1.2, -0.16]ANCOVA
Secondary
Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score at Week 36
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.
Time frame: Baseline, Week 36
Population: All randomized participants with baseline and at least one postbaseline HADS anxiety score. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score at Week 36 | -0.47 score on a scale | Standard Error 0.225 |
| 2 mg Baricitinib | Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score at Week 36 | -0.67 score on a scale | Standard Error 0.227 |
| 4 mg Baricitinib | Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score at Week 36 | -1.19 score on a scale | Standard Error 0.181 |
p-value: 0.51895% CI: [-0.82, 0.42]ANCOVA
p-value: 0.01295% CI: [-1.28, -0.16]ANCOVA
Secondary
Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50)
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.
Time frame: Week 12
Population: All randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) | 2.6 percentage of participants |
| 2 mg Baricitinib | Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) | 10.9 percentage of participants |
| 4 mg Baricitinib | Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) | 23.5 percentage of participants |
p-value: 0.00595% CI: [1.58, 13.6]Regression, Logistic
p-value: <0.00195% CI: [4.72, 35.44]Regression, Logistic
Secondary
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)
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.
Time frame: Week 36
Population: All randomized participants with baseline ClinRO measure for EB hair loss ≥ 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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) | 4.5 percentage of participants |
| 2 mg Baricitinib | 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) | 11.5 percentage of participants |
| 4 mg Baricitinib | 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) | 34.8 percentage of participants |
p-value: 0.07695% CI: [0.91, 7.24]Regression, Logistic
p-value: <0.00195% CI: [4.12, 25.77]Regression, Logistic
Secondary
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)
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.
Time frame: Week 36
Population: All randomized participants with baseline ClinRO measure for EL hair loss ≥ 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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) | 5.6 percentage of participants |
| 2 mg Baricitinib | 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) | 10.1 percentage of participants |
| 4 mg Baricitinib | 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) | 34.3 percentage of participants |
p-value: 0.2695% CI: [0.63, 5.62]Regression, Logistic
p-value: <0.00195% CI: [3.18, 20.66]Regression, Logistic
Secondary
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)
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.
Time frame: Week 36
Population: All randomized participants with baseline PRO measures for EB hair loss ≥2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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) | 4.7 percentage of participants |
| 2 mg Baricitinib | 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) | 14.8 percentage of participants |
| 4 mg Baricitinib | 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) | 35.8 percentage of participants |
p-value: 0.01795% CI: [1.25, 9.4]Regression, Logistic
p-value: <0.00195% CI: [4.32, 27.25]Regression, Logistic
Secondary
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)
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.
Time frame: Week 36
Population: All randomized participants with baseline PRO Measure EL hair loss ≥2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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) | 1.1 percentage of participants |
| 2 mg Baricitinib | 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) | 18.9 percentage of participants |
| 4 mg Baricitinib | 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) | 34.6 percentage of participants |
p-value: 0.00295% CI: [2.73, 78.42]Regression, Logistic
p-value: <0.00195% CI: [5.93, 99.99]Regression, Logistic
Secondary
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
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).
Time frame: Week 36
Population: All randomized participants with baseline PRO for scalp hair assessment score of ≥ 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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 | 4.0 percentage of participants |
| 2 mg Baricitinib | 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 | 16.1 percentage of participants |
| 4 mg Baricitinib | 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 | 34.4 percentage of participants |
p-value: 0.00195% CI: [1.77, 10.74]Regression, Logistic
p-value: <0.00195% CI: [5.75, 31.1]Regression, Logistic
Secondary
Percent Change From Baseline in SALT Score at Week 36
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.
Time frame: Baseline, Week 36
Population: All randomized participants with nonmissing baseline and at least one postbaseline measure. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline in SALT Score at Week 36 | -2.96 percentage of change | Standard Error 2.723 |
| 2 mg Baricitinib | Percent Change From Baseline in SALT Score at Week 36 | -28.21 percentage of change | Standard Error 2.77 |
| 4 mg Baricitinib | Percent Change From Baseline in SALT Score at Week 36 | -47.45 percentage of change | Standard Error 2.229 |
p-value: <0.00195% CI: [-32.78, -17.72]ANCOVA
p-value: <0.00195% CI: [-51.33, -37.65]ANCOVA
Secondary
Time for Participants to Achieve SALT ≤ 20
Time for participants to achieve SALT ≤ 20
Time frame: Week 52