A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata

Study Overview
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Brief Summary
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The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).

Official Title
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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

Conditions
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Alopecia Areata

Intervention / Treatment
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* Drug: Baricitinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4 Milligram (mg) Baricitinib<br>Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind. | Drug: Baricitinib<br>* Administered orally<br>* Other names: LY3009104;Drug: Placebo<br>* Administered orally<br>|
| Experimental: 2 mg Baricitinib<br>Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind. | Drug: Baricitinib<br>* Administered orally<br>* Other names: LY3009104;Drug: Placebo<br>* Administered orally<br>|
| Placebo Comparator: Placebo<br>Participants received two placebo tablets administered orally QD to maintain the blind. | Drug: Placebo<br>* Administered orally<br>|
| Experimental: 4 mg Baricitinib Maximum Extended Enrollment (MEE)<br>Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind. | Drug: Baricitinib<br>* Administered orally<br>* Other names: LY3009104;Drug: Placebo<br>* Administered orally<br>|
| Experimental: 2 mg Baricitinib MEE<br>Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind. | Drug: Baricitinib<br>* Administered orally<br>* Other names: LY3009104;|
| Placebo Comparator: Placebo MEE<br>Participants received two placebo tablets administered orally QD to maintain the blind. | Drug: Placebo<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 | Percentage of Participants Achieving SALT ≤ 20 | Week 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change from Baseline in SALT score | Percent change from baseline in SALT score | Baseline, Week 36 | 
| Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) | Percentage of participants achieving SALT50 | Week 12 | 
| 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 | Percentage of participants with 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 | 
| Time for Participants to Achieve SALT ≤ 20 | Time for Participants to Achieve SALT ≤ 20 | Baseline through Week 36 | 
| 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) | Percentage of participants achieving ClinRO measure for 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 | 
| 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) | Percentage of participants achieving ClinRO measure for 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 | 
| 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) | 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) | Week 36 | 
| 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) | 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 | 
| Change from Baseline in Skindex-16 AA Symptoms Domain Score | Change from Baseline in Skindex-16 AA Symptoms Domain Score | Baseline, Week 36 | 
| Change from Baseline in Skindex-16 AA Emotions Domain Score | Change from Baseline in Skindex-16 AA Emotions Domain Score | Baseline, Week 36 | 
| Change from Baseline in Skindex-16 AA Functioning Domain Score | Change from Baseline in Skindex-16 AA Functioning Domain Score | Baseline, Week 36 | 
| Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score | Mean Change From Baseline in HADS Anxiety Score | Week 36 | 
| Mean Change From Baseline in HADS Depression Score | Mean Change From Baseline in HADS Depression Score | Week 36 |