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

Sponsor
Arena Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04556734
Collaborator
(none)
78
29
3
37
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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

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double-Blind, Placebo-ControlledDouble-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 :
Aug 31, 2020
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Etrasimod 2 mg

Drug: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily
Other Names:
  • APD334
  • Experimental: Etrasimod 3 mg

    Drug: Etrasimod
    Etrasimod 3 mg (1 mg and 2 mg tablets) by mouth, once daily
    Other Names:
  • APD334
  • Placebo Comparator: Placebo

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

    Outcome Measures

    Primary Outcome Measures

    1. Percent Change From Baseline in Severity of Alopecia Tool (SALT) [Baseline to Week 24]

    Secondary Outcome Measures

    1. Change From Baseline in SALT [Baseline to Week 24]

    2. Proportion of Participants Achieving ≥30% Improvement From Baseline in SALT [Baseline to Week 24]

    3. Proportion of Participants Achieving ≥50% Improvement From Baseline in SALT [Baseline to Week 24]

    4. Proportion of Participants Achieving ≥75% Improvement From Baseline in SALT [Baseline to Week 24]

    5. 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

    Ages Eligible for Study:
    18 Years to 70 Years
    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

    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.
    Responsible Party:
    Arena Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04556734
    Other Study ID Numbers:
    • APD334-205
    First Posted:
    Sep 21, 2020
    Last Update Posted:
    Mar 16, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Arena Pharmaceuticals
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 16, 2022