Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04556734 |
Recruitment Status :
Recruiting
First Posted : September 21, 2020
Last Update Posted : February 9, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alopecia Areata | Drug: Etrasimod Drug: Placebo | Phase 2 |
Study Type : | Interventional |
Estimated Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Double-Blind, Placebo-Controlled |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | August 31, 2020 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | June 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Etrasimod 2 mg |
Drug: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily
Other Name: APD334 |
Placebo Comparator: Placebo |
Drug: Placebo
Etrasimod 2 mg matching placebo tablet by mouth, once daily |
- Percent Change From Baseline in Severity of Alopecia Tool (SALT) [ Time Frame: Baseline to Week 24 ]
- Change From Baseline in SALT [ Time Frame: Baseline to Week 24 ]
- Proportion of Participants Achieving a 30% Improvement From Baseline in SALT (SALT30) [ Time Frame: Baseline to Week 24 ]
- Proportion of Participants Achieving a 50% Improvement From Baseline in SALT (SALT50) [ Time Frame: Baseline to Week 24 ]
- Proportion of Participants Achieving a 75% Improvement From Baseline in SALT (SALT75) [ Time Frame: Baseline to Week 24 ]
- Number and Severity of Adverse Events (Double-Blind Treatment Period and Open-Label Extension Period) [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Men or women between ≥18 and ≤70 years of age at the time of informed consent
- Moderate-to-severe alopecia areata (AA) as assessed by a SALT score of ≥50
- Current episode of hair loss for ≥6 months but <8 years
- Stable disease condition (ie, no significant growth or loss 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04556734
Contact: Arena CT.gov Administrator | +1 855-218-9153 | ct.gov@arenapharm.com |
United States, Arizona | |
Investigate MD | Recruiting |
Scottsdale, Arizona, United States, 85255 | |
United States, Arkansas | |
Dermatology Trial Associates | Recruiting |
Bryant, Arkansas, United States, 72022 | |
United States, California | |
University of California | Recruiting |
Irvine, California, United States, 92697 | |
United States, Connecticut | |
Yale Center for Clinical Investigation | Recruiting |
New Haven, Connecticut, United States, 06519 | |
United States, Florida | |
Leavitt Medical Associates of Florida, Inc d/b/a Ameriderm Research | Recruiting |
Ormond Beach, Florida, United States, 32174 | |
United States, Michigan | |
Michigan Center for Skin Care Research | Recruiting |
Clinton Township, Michigan, United States, 48038 | |
United States, Oregon | |
NW Dermatology Institute | Recruiting |
Portland, Oregon, United States, 97210 | |
United States, Tennessee | |
International Clinical Research - Tennessee LLC | Recruiting |
Murfreesboro, Tennessee, United States, 37130 | |
United States, Texas | |
Progressive Clinical Research, PA | Recruiting |
San Antonio, Texas, United States, 78213 | |
United States, Washington | |
Dermatology Specialists of Spokane | Recruiting |
Spokane, Washington, United States, 99202 | |
Canada, Quebec | |
Innovaderm Research Inc. | Recruiting |
Montreal, Quebec, Canada, H2X 2V1 |
Study Director: | Arena CT.gov Administrator | Arena Pharmaceuticals |
Responsible Party: | Arena Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT04556734 |
Other Study ID Numbers: |
APD334-205 |
First Posted: | September 21, 2020 Key Record Dates |
Last Update Posted: | February 9, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
T-cell-mediated autoimmune skin disorder Alopecia areata Alopecia |
APD334 Etrasimod Hair loss |
Alopecia Alopecia Areata Hypotrichosis |
Hair Diseases Skin Diseases Pathological Conditions, Anatomical |