Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata
NCT ID: NCT04556734
Last Updated: 2024-06-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2020-07-29
2023-06-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Etrasimod 2 mg
Etrasimod
Etrasimod 2 mg tablet by mouth, once daily
Etrasimod 3 mg
Etrasimod
Etrasimod 3 mg (1 mg and 2 mg tablets) by mouth, once daily
Placebo
Placebo
Etrasimod matching placebo tablet by mouth, once daily
Interventions
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Etrasimod
Etrasimod 2 mg tablet by mouth, once daily
Etrasimod
Etrasimod 3 mg (1 mg and 2 mg tablets) by mouth, once daily
Placebo
Etrasimod matching placebo tablet by mouth, once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Arena is a wholly owned subsidiary of Pfizer
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Investigate MD
Scottsdale, Arizona, United States
Dermatology Trial Associates
Bryant, Arkansas, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
First OC Dermatology
Fountain Valley, California, United States
University of California,Irvine
Irvine, California, United States
Prospect Optometry
Lomita, California, United States
Torrance Clinical Research Institute,Inc.
Lomita, California, United States
Yale Eye Center
New Haven, Connecticut, United States
Yale Investigational Drug Services
New Haven, Connecticut, United States
Yale Center for Clinical Investigation
New Haven, Connecticut, United States
Yale New Haven Hospital Department of Respiratory Care
New Haven, Connecticut, United States
Advanced Sleep & Respiratory Institute, PA
Daytona Beach, Florida, United States
International Eye Associates
Ormond Beach, Florida, United States
Leavitt Medical Associates of Florida d/ba Ameriderm Research
Ormond Beach, Florida, United States
Advanced Clinical Research Institute
Tampa, Florida, United States
Advanced Medical Research PC
Sandy Springs, Georgia, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Eye Surgeons of Indiana
Indianapolis, Indiana, United States
Magnante Eye Care (Ophthalmological Assessments)
Lafayette, Indiana, United States
Physicians Research Group (Administrative Office Location)
Noblesville, Indiana, United States
Physicians Research Group
West Lafayette, Indiana, United States
Randall Dermatology, PC
West Lafayette, Indiana, United States
Lawrence J. Green, MD LLC
Rockville, Maryland, United States
Michigan Center for Skin Care Research
Clinton Township, Michigan, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
NYC Retina- Manhattan
New York, New York, United States
Bobby Buka MD, PC
New York, New York, United States
Rochester Ophthalmological Group
Rochester, New York, United States
Skin Search of Rochester, Inc.
Rochester, New York, United States
WDC Cosmetic and Research, PLLC
Wilmington, North Carolina, United States
NW Dermatology Institute
Portland, Oregon, United States
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, United States
UPMC Eye Center
Pittsburgh, Pennsylvania, United States
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, United States
Progressive Clinical Research, PA
San Antonio, Texas, United States
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States
Dermatology Specialists of Spokane
Spokane, Washington, United States
PRINCIPLE RESEARCH SOLUTIONS (pulmonary function testing)
Spokane, Washington, United States
SPOKANE EYE CLINIC (OCT and optical exam
Spokane, Washington, United States
Dermatology Research Institute
Calgary, Alberta, Canada
Laser Rejuvenation Clinics Edmonton D.T. Inc.
Edmonton, Alberta, Canada
Innovaderm Research
Montreal, Quebec, Canada
Countries
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References
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King B, Mesinkovska N, Senna M, Luo X, Minkiewicz J, Selfridge A. Efficacy and safety of etrasimod in alopecia areata: A multicentre, randomized, double-blind, placebo-controlled, Phase 2 study. J Eur Acad Dermatol Venereol. 2025 Jun;39(6):1174-1184. doi: 10.1111/jdv.20605. Epub 2025 Mar 27.
Dubinsky MC, Wu J, McDonnell A, Lazin K, Goetsch M, Branquinho D, Modesto I, Armuzzi A. Low Incidence of Macular Edema and Other Ocular Events in the Etrasimod Development Program. J Crohns Colitis. 2025 May 8;19(5):jjae173. doi: 10.1093/ecco-jcc/jjae173.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C5041008
Identifier Type: OTHER
Identifier Source: secondary_id
APD334-205
Identifier Type: -
Identifier Source: org_study_id
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