Alopecia Areata
Conditions
Brief summary
This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata. An additional subpopulation of 60 participants in the US will enroll in the open-label addenda.
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. * Must self-identify as either Black or African American in race in the open label addenda. * 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 -- Severity of Alopecia Tool (SALT) Alopecia Areata (AA) Investigator Global Assessment (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. * 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 - Phase 3 | 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. |
| Percent Change From Baseline in SALT Score - Phase 3 Open-Label Addendum | Baseline, Week 52 | 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 - Phase 3 | Baseline, 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. 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 SALT (SALT50) - Phase 3 | 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. |
| Time for Participants to Achieve SALT ≤ 20 at Week 36 - Phase 3 | 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) - Phase 3 | 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) - Phase 3 | 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 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 - Phase 3 | Week 36 | PRO is an assessment of the participant'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). |
| Percentage of Participants Achieving PRO Measure for EB 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥ 2 at Baseline) - Phase 3 | 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) - Phase 3 | 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. |
| Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score - Phase 3 | Baseline, Week 36 | The Hospital Anxiety Depression Scale (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 (e.g., 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 - Phase 3 | 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 (e.g., 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. |
| Percentage of Participants Achieving SALT ≤ 20 - Phase 3 Open-Label Addendum | Week 52 | 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. |
| Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3 Open-Label Addendum | Week 52 | 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. |
| Percentage of Participants Achieving 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) - Phase 3 Open-Label Addendum | Week 52 | 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) - Phase 3 Open-Label Addendum | Week 52 | 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 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 - Phase 3 Open-Label Addendum | Week 52 | PRO is an assessment of the participant'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). |
Countries
Japan, Mexico, Puerto Rico, South Korea, 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
Recruitment details
The study was conducted in three separate parts with no participant overlap: • Phase 2 (Weeks 0-200): Participants completed 12 weeks of treatment or early discontinuation. At Week 12, an interim analysis was conducted to determine doses for Phase 3. Based on these Phase 2 interim results, subsequent participants in Phase 3 were enrolled and assigned to receive either baricitinib 2 mg or 4 mg.
Pre-assignment details
* Phase 3 (Weeks 0-248): This phase 3 consisted of two treatment periods: Treatment Period 1 (Weeks 0-52) and Treatment Period 2 (Weeks 52-248), which included randomized withdrawal of baricitinib doses among responders and uptitration among baricitinib 2 mg nonresponders. * Phase 3 Open-Label Addendum (Weeks 0-52): An additional 20 Black or African American participants were enrolled in the United States to evaluate the effectiveness of baricitinib therapy.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Phase 2 Participants received three placebo tablets administered orally every day (QD). | 28 |
| 1 mg Baricitinib Phase 2 Participants received one 1 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind. | 28 |
| 2 mg Baricitinib Phase 2 Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind. | 27 |
| 4 mg Baricitinib Phase 2 Participants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablet administered orally QD to maintain the blind. | 27 |
| Placebo Phase 3 Participants received two placebo tablets administered orally QD. | 189 |
| 2 mg Baricitinib Phase 3 Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind. | 184 |
| 4 mg Baricitinib Phase 3 Participants received one 4 mg Baricitinib tablet administered orally, QD and one placebo tablet QD administered orally to maintain the blind. | 281 |
| Total | 764 |
Baseline characteristics
| Characteristic | Placebo Phase 2 | 1 mg Baricitinib Phase 2 | 2 mg Baricitinib Phase 2 | 4 mg Baricitinib Phase 2 | Placebo Phase 3 | 2 mg Baricitinib Phase 3 | 4 mg Baricitinib Phase 3 | Total | — |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 40.5 years STANDARD_DEVIATION 14.23 | 38.6 years STANDARD_DEVIATION 11.26 | 42.5 years STANDARD_DEVIATION 13.75 | 42.4 years STANDARD_DEVIATION 14.91 | 37.4 years STANDARD_DEVIATION 12.91 | 38.0 years STANDARD_DEVIATION 12.78 | 36.3 years STANDARD_DEVIATION 13.27 | 46.0 years STANDARD_DEVIATION 8.75 | 37.8 years STANDARD_DEVIATION 13 |
| Baseline Disease Severity of Alopecia Tool (SALT) Score | 90.0 units on a scale STANDARD_DEVIATION 15.69 | 89.3 units on a scale STANDARD_DEVIATION 17.65 | 86.1 units on a scale STANDARD_DEVIATION 19.32 | 83.4 units on a scale STANDARD_DEVIATION 17.52 | 84.7 units on a scale STANDARD_DEVIATION 17.82 | 86.8 units on a scale STANDARD_DEVIATION 18.01 | 85.3 units on a scale STANDARD_DEVIATION 18.18 | 79.1 units on a scale STANDARD_DEVIATION 21.28 | 85.6 units on a scale STANDARD_DEVIATION 17.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 8 Participants | 5 Participants | 8 Participants | 0 Participants | 22 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 3 Participants | 4 Participants | 78 Participants | 76 Participants | 114 Participants | 0 Participants | 282 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 3 Participants | 3 Participants | 17 Participants | 7 Participants | 28 Participants | 19 Participants | 83 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 6 Participants | 1 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) White | 21 Participants | 22 Participants | 20 Participants | 19 Participants | 83 Participants | 93 Participants | 123 Participants | 0 Participants | 381 Participants |
| Region of Enrollment Japan | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 12 Participants |
| Region of Enrollment Mexico | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 16 Participants | 12 Participants | 21 Participants | 0 Participants | 49 Participants |
| Region of Enrollment South Korea | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 70 Participants | 70 Participants | 107 Participants | 0 Participants | 247 Participants |
| Region of Enrollment United States | 25 Participants | 25 Participants | 24 Participants | 24 Participants | 103 Participants | 102 Participants | 153 Participants | 20 Participants | 476 Participants |
| Sex: Female, Male Female | 16 Participants | 18 Participants | 23 Participants | 25 Participants | 109 Participants | 109 Participants | 165 Participants | 15 Participants | 480 Participants |
| Sex: Female, Male Male | 12 Participants | 10 Participants | 4 Participants | 2 Participants | 80 Participants | 75 Participants | 116 Participants | 5 Participants | 304 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 27 | 0 / 27 | 0 / 106 | 0 / 189 | 0 / 183 | 0 / 280 | 0 / 619 | 0 / 19 |
| other Total, other adverse events | 12 / 28 | 21 / 27 | 19 / 27 | 79 / 106 | 37 / 189 | 58 / 183 | 126 / 280 | 275 / 619 | 13 / 19 |
| serious Total, serious adverse events | 0 / 28 | 0 / 27 | 2 / 27 | 3 / 106 | 3 / 189 | 7 / 183 | 16 / 280 | 40 / 619 | 1 / 19 |
Outcome results
Primary
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 - Phase 3
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 in Phase 3 portion, in both Stages 1 and 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Phase 3 | Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 - Phase 3 | 5.3 percentage of participants |
| 2 mg Baricitinib Phase 3 | Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 - Phase 3 | 21.7 percentage of participants |
| 4 mg Baricitinib Phase 3 | Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 - Phase 3 | 35.2 percentage of participants |
p-value: <0.00195% CI: [2.75, 12.02]Regression, Logistic
p-value: <0.00195% CI: [5.89, 23.62]Regression, Logistic
Secondary
Mean Change From Baseline in HADS Depression Score - Phase 3
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 (e.g., 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 in Phase 3 portion, Stages 1 and 2 with a nonmissing baseline and at least one postbaseline measure. The method used to handle missing data will be mLOCF which used the most recent nonmissing postbaseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Phase 3 | Mean Change From Baseline in HADS Depression Score - Phase 3 | 0.04 score on a scale | Standard Error 0.21 |
| 2 mg Baricitinib Phase 3 | Mean Change From Baseline in HADS Depression Score - Phase 3 | -0.38 score on a scale | Standard Error 0.213 |
| 4 mg Baricitinib Phase 3 | Mean Change From Baseline in HADS Depression Score - Phase 3 | -0.28 score on a scale | Standard Error 0.179 |
p-value: 0.10795% CI: [-0.93, 0.09]ANCOVA
p-value: 0.17495% CI: [-0.78, 0.14]ANCOVA
Secondary
Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score - Phase 3
The Hospital Anxiety Depression Scale (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 (e.g., 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 in Phase 3 portion, Stages 1 and 2 with a nonmissing baseline and at least one postbaseline measure. The method used to handle missing data will be mLOCF which used the most recent nonmissing postbaseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Phase 3 | Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score - Phase 3 | -0.40 score on a scale | Standard Error 0.234 |
| 2 mg Baricitinib Phase 3 | Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score - Phase 3 | -1.22 score on a scale | Standard Error 0.236 |
| 4 mg Baricitinib Phase 3 | Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score - Phase 3 | -0.93 score on a scale | Standard Error 0.199 |
p-value: 0.00595% CI: [-1.38, -0.25]ANCOVA
p-value: 0.0495% CI: [-1.05, -0.02]ANCOVA
Secondary
Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3
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 12
Population: All randomized participants in Phase 3 portion, in both Stages 1 and 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Phase 3 | Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3 | 4.8 percentage of participants |
| 2 mg Baricitinib Phase 3 | Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3 | 9.8 percentage of participants |
| 4 mg Baricitinib Phase 3 | Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3 | 21.7 percentage of participants |
p-value: 0.04795% CI: [1.01, 5.29]Regression, Logistic
p-value: <0.00195% CI: [2.91, 12.51]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) - Phase 3
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 in Phase 3 portion, in both Stages 1 and 2 with baseline ClinRO measure for EB Hair Loss ≥ 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Phase 3 | 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) - Phase 3 | 3.2 percentage of participants |
| 2 mg Baricitinib Phase 3 | 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) - Phase 3 | 19.1 percentage of participants |
| 4 mg Baricitinib Phase 3 | 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) - Phase 3 | 31.4 percentage of participants |
p-value: <0.00195% CI: [2.34, 18.62]Regression, Logistic
p-value: <0.00195% CI: [5.01, 36.81]Regression, Logistic
Secondary
Percentage of Participants Achieving ClinRO Measure for Eye Lash (EL) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥ 2 at Baseline) - Phase 3
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 in Phase 3 portion, in both Stages 1 and 2 with baseline ClinRO measure for EL hair loss ≥ 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Phase 3 | Percentage of Participants Achieving ClinRO Measure for Eye Lash (EL) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥ 2 at Baseline) - Phase 3 | 3.1 percentage of participants |
| 2 mg Baricitinib Phase 3 | Percentage of Participants Achieving ClinRO Measure for Eye Lash (EL) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥ 2 at Baseline) - Phase 3 | 13.5 percentage of participants |
| 4 mg Baricitinib Phase 3 | Percentage of Participants Achieving ClinRO Measure for Eye Lash (EL) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥ 2 at Baseline) - Phase 3 | 33.5 percentage of participants |
p-value: 0.01295% CI: [1.41, 15.27]Regression, Logistic
p-value: <0.00195% CI: [4.73, 43.93]Regression, Logistic
Secondary
Percentage of Participants Achieving PRO Measure for EB 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥ 2 at Baseline) - Phase 3
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 in Phase 3 portion, in both Stages 1 and 2 with baseline PRO measure for EB ≥ 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Phase 3 | Percentage of Participants Achieving PRO Measure for EB 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥ 2 at Baseline) - Phase 3 | 3.1 percentage of participants |
| 2 mg Baricitinib Phase 3 | Percentage of Participants Achieving PRO Measure for EB 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥ 2 at Baseline) - Phase 3 | 16.3 percentage of participants |
| 4 mg Baricitinib Phase 3 | Percentage of Participants Achieving PRO Measure for EB 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥ 2 at Baseline) - Phase 3 | 32.1 percentage of participants |
p-value: 0.00195% CI: [1.97, 15.83]Regression, Logistic
p-value: <0.00195% CI: [5.3, 38.83]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) - Phase 3
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 in Phase 3 portion, in both Stages 1 and 2 with baseline PRO measure for EL ≥ 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Phase 3 | 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) - Phase 3 | 2.0 percentage of participants |
| 2 mg Baricitinib Phase 3 | 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) - Phase 3 | 19.6 percentage of participants |
| 4 mg Baricitinib Phase 3 | 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) - Phase 3 | 29.8 percentage of participants |
p-value: <0.00195% CI: [5.04, 67.68]Regression, Logistic
p-value: <0.00195% CI: [2.72, 39.3]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 - Phase 3
PRO is an assessment of the participant'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 in Phase 3 portion, in both Stages 1 and 2 with baseline PRO for scalp hair assessment of ≥ 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Phase 3 | 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 - Phase 3 | 5.0 percentage of participants |
| 2 mg Baricitinib Phase 3 | 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 - Phase 3 | 16.0 percentage of participants |
| 4 mg Baricitinib Phase 3 | 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 - Phase 3 | 33.1 percentage of participants |
p-value: <0.00195% CI: [1.81, 8.51]Regression, Logistic
p-value: <0.00195% CI: [5.05, 20.87]Regression, Logistic
Secondary
Percent Change From Baseline in SALT Score - Phase 3
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 worse 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 in Phase 3 portion, Stages 1 and 2 with a nonmissing baseline and least one postbaseline measures. A modified last observation carried forward (mLOCF) imputation technique was used to replace missing data with the most recent non-missing post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Phase 3 | Percent Change From Baseline in SALT Score - Phase 3 | -8.13 percent change | Standard Error 3.1 |
| 2 mg Baricitinib Phase 3 | Percent Change From Baseline in SALT Score - Phase 3 | -31.23 percent change | Standard Error 3.157 |
| 4 mg Baricitinib Phase 3 | Percent Change From Baseline in SALT Score - Phase 3 | -45.79 percent change | Standard Error 2.663 |
p-value: <0.00195% CI: [-30.57, -15.63]ANCOVA
p-value: <0.00195% CI: [-44.24, -30.89]ANCOVA
Secondary
Time for Participants to Achieve SALT ≤ 20
Time for participants to achieve SALT ≤ 20
Time frame: Week 52