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

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. Identifier: NCT04556734
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : September 28, 2021
Information provided by (Responsible Party):
Arena Pharmaceuticals

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
Alopecia Areata Drug: Etrasimod Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 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 : May 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Etrasimod 2 mg Drug: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily
Other Name: APD334

Experimental: Etrasimod 3 mg Drug: Etrasimod
Etrasimod 3 mg (1 mg and 2 mg tablets) by mouth, once daily
Other Name: APD334

Placebo Comparator: Placebo Drug: Placebo
Etrasimod matching placebo tablet by mouth, once daily

Primary Outcome Measures :
  1. Percent Change From Baseline in Severity of Alopecia Tool (SALT) [ Time Frame: Baseline to Week 24 ]

Secondary Outcome Measures :
  1. Change From Baseline in SALT [ Time Frame: Baseline to Week 24 ]
  2. Proportion of Participants Achieving ≥30% Improvement From Baseline in SALT [ Time Frame: Baseline to Week 24 ]
  3. Proportion of Participants Achieving ≥50% Improvement From Baseline in SALT [ Time Frame: Baseline to Week 24 ]
  4. Proportion of Participants Achieving ≥75% Improvement From Baseline in SALT [ Time Frame: Baseline to Week 24 ]
  5. 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.

Information from the National Library of Medicine

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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 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT04556734

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Contact: Arena Administrator +1 855-218-9153

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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
First OC Dermatology Recruiting
Fountain Valley, California, United States, 92708
University of California Recruiting
Irvine, California, United States, 92697
Stanford University School of Medicine-Medical Dermatology Recruiting
Redwood City, California, United States, 94063
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 Withdrawn
Ormond Beach, Florida, United States, 32174
United States, Michigan
Michigan Center for Skin Care Research Recruiting
Clinton Township, Michigan, United States, 48038
United States, New York
Skin Search of Rochester, Inc. Recruiting
Rochester, New York, United States, 14623
United States, North Carolina
Wilmington Dermatology Center Recruiting
Wilmington, North Carolina, United States, 28405
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
Sponsors and Collaborators
Arena Pharmaceuticals
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Study Director: Arena Administrator Arena Pharmaceuticals
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Responsible Party: Arena Pharmaceuticals Identifier: NCT04556734    
Other Study ID Numbers: APD334-205
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arena Pharmaceuticals:
T-cell-mediated autoimmune skin disorder
Alopecia areata
Hair loss
Additional relevant MeSH terms:
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Alopecia Areata
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical