Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of etrasimod monotherapy (2 milligrams [mg] and 3 mg) in participants with moderate-to-severe alopecia areata (AA).

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-Week Study, With a 28-Week Open-Label Extension, to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Alopecia Areata

Conditions
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Alopecia Areata

Intervention / Treatment
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* Drug: Etrasimod
* Drug: Etrasimod
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Men or women between ≥18 and ≤70 years of age at the time of informed consent Moderate-to-severe alopecia areata as assessed by a SALT score of ≥25 and <95 at Screening and Day 1/Baseline. Current episode of hair loss for ≥6 months but <5 years Stable disease condition (no significant growth of hair) in the last 6 months as assessed by the Investigator Willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the study Key Exclusion Criteria: History of male or female pattern hair loss >Hamilton stage III or >Ludwig stage II Other types of alopecia (eg, cicatricial/scarring alopecia [including central centrifugal cicatricial alopecia], traction alopecia, or telogen effluvium) or other diseases that could cause hair loss Active scalp inflammation, scalp infection, scalp psoriasis, or any other scalp condition that may interfere with the SALT assessment Previous use of Janus kinase (JAK) inhibitor (oral or topical), including participation in clinical studies of JAK inhibitors

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
Interventional Model Description: Double-Blind, Placebo-Controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etrasimod 2 mg<br> | Drug: Etrasimod<br>* Etrasimod 2 mg tablet by mouth, once daily<br>* Other names: APD334;|
| Experimental: Etrasimod 3 mg<br> | Drug: Etrasimod<br>* Etrasimod 3 mg (1 mg and 2 mg tablets) by mouth, once daily<br>* Other names: APD334;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Etrasimod matching placebo tablet by mouth, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Severity of Alopecia Tool (SALT) |  | Baseline to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in SALT |  | Baseline to Week 24 | 
| Proportion of Participants Achieving ≥30% Improvement From Baseline in SALT |  | Baseline to Week 24 | 
| Proportion of Participants Achieving ≥50% Improvement From Baseline in SALT |  | Baseline to Week 24 | 
| Proportion of Participants Achieving ≥75% Improvement From Baseline in SALT |  | Baseline to Week 24 | 
| Number and Severity of Adverse Events (Double-Blind Treatment Period and Open-Label Extension Period) | Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results. | Up to approximately 56 weeks (24-weeks of Double-Blind Treatment Period, 28-weeks of Open-Label Extension Period, and 4-weeks of Safety Follow-Up Period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T-cell-mediated autoimmune skin disorder, Alopecia areata, Alopecia, APD334, Etrasimod, Hair loss