Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata
Study Details
Study Description
Brief Summary
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Etrasimod 2 mg
|
Drug: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily
Other Names:
|
Experimental: Etrasimod 3 mg
|
Drug: Etrasimod
Etrasimod 3 mg (1 mg and 2 mg tablets) by mouth, once daily
Other Names:
|
Placebo Comparator: Placebo
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Drug: Placebo
Etrasimod matching placebo tablet by mouth, once daily
|
Outcome Measures
Primary Outcome Measures
- Percent Change From Baseline in Severity of Alopecia Tool (SALT) [Baseline to Week 24]
Secondary Outcome Measures
- 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) [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)]
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Men or women between ≥18 and ≤70 years of age at the time of informed consent
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Moderate-to-severe alopecia areata as assessed by a SALT score of ≥25 and <95 at Screening and Day 1/Baseline.
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Current episode of hair loss for ≥6 months but <5 years
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Stable disease condition (no significant growth of hair) in the last 6 months as assessed by the Investigator
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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:
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History of male or female pattern hair loss >Hamilton stage III or >Ludwig stage II
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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
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Active scalp inflammation, scalp infection, scalp psoriasis, or any other scalp condition that may interfere with the SALT assessment
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Previous use of Janus kinase (JAK) inhibitor (oral or topical), including participation in clinical studies of JAK inhibitors
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Investigate MD | Scottsdale | Arizona | United States | 85255 |
2 | Dermatology Trial Associates | Bryant | Arkansas | United States | 72022 |
3 | California Dermatology & Clinical Research Institute | Encinitas | California | United States | 92024 |
4 | First OC Dermatology | Fountain Valley | California | United States | 92708 |
5 | University of California | Irvine | California | United States | 92697 |
6 | Torrance Clinical Research Institute, Inc | Lomita | California | United States | 90717 |
7 | Stanford University School of Medicine-Medical Dermatology | Redwood City | California | United States | 94063 |
8 | Yale Center for Clinical Investigation | New Haven | Connecticut | United States | 06519 |
9 | Leavitt Medical Associates of Florida, Inc d/b/a Ameriderm Research | Ormond Beach | Florida | United States | 32174 |
10 | Advanced Clinical Research Institute | Tampa | Florida | United States | 33607 |
11 | Advance Medical Research PC | Sandy Springs | Georgia | United States | 30328 |
12 | Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | United States | 46250 |
13 | Physicians Research Group | West Lafayette | Indiana | United States | 47906 |
14 | Lawrence J Green, MD; LLC | Rockville | Maryland | United States | 20850 |
15 | Michigan Center for Skin Care Research | Clinton Township | Michigan | United States | 48038 |
16 | MediSearch Clinical Trials | Saint Joseph | Missouri | United States | 64506 |
17 | Bobby Buka MD, PC | New York | New York | United States | 10012 |
18 | Skin Search of Rochester, Inc. | Rochester | New York | United States | 14623 |
19 | Wilmington Dermatology Center | Wilmington | North Carolina | United States | 28405 |
20 | Central Sooner Research | Norman | Oklahoma | United States | 73071 |
21 | NW Dermatology Institute | Portland | Oregon | United States | 97210 |
22 | UPMC Department of Dermatology | Pittsburgh | Pennsylvania | United States | 15213 |
23 | International Clinical Research - Tennessee LLC | Murfreesboro | Tennessee | United States | 37130 |
24 | Progressive Clinical Research, PA | San Antonio | Texas | United States | 78213 |
25 | The Education and Research Foundation, Inc | Lynchburg | Virginia | United States | 24501 |
26 | Dermatology Specialists of Spokane | Spokane | Washington | United States | 99202 |
27 | Dermatology Research Institute | Calgary | Alberta | Canada | T2J 7E1 |
28 | Laser Rejuvenation Clinics Edmonton D.T. Inc. | Edmonton | Alberta | Canada | T5J 3S9 |
29 | Innovaderm Research Inc. | Montréal | Quebec | Canada | H2X 2V1 |
Sponsors and Collaborators
- Arena Pharmaceuticals
Investigators
- Study Director: Arena CT.gov Administrator, Arena Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APD334-205