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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 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. 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 SALT Alopecia Areata 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).

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: Baricitinib High Dose<br>Baricitinib administered orally. Placebo administered orally to maintain the blind. | Drug: Baricitinib<br>* Administered orally.<br>* Other names: LY3009104;Drug: Placebo<br>* Administered orally.<br>|
| Experimental: Baricitinib Low Dose<br>Baricitinib administered orally. Placebo administered orally to maintain the blind. | Drug: Baricitinib<br>* Administered orally.<br>* Other names: LY3009104;Drug: Placebo<br>* Administered orally.<br>|
| Placebo Comparator: Placebo<br>Participants administered orally. | Drug: Placebo<br>* Administered orally.<br>|
| Experimental: Open-Label Addenda Baricitinib High Dose<br>Baricitinib will be administered orally during the open-label addenda. | Drug: Baricitinib<br>* Administered orally.<br>* Other names: LY3009104;|

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 |
| --- | --- | --- |
| Percentage of Participants Achieving 50% Improvement of SALT (SALT50) | Percentage of participants achieving SALT50 | Week 12 | 
| Percent Change from Baseline in SALT Score | Percent change from baseline in SALT score | 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 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) | 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 Patient Reported Outcome (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 | 
| 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 |