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

NCT04556734 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: APD334-205C5041008
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 42

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).

Conditions

Alopecia Areata

Keywords

T-cell-mediated autoimmune skin disorder; Alopecia areata; Alopecia; APD334; Etrasimod; Hair loss

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment Period

  SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage (%) of scalp surface area involved on the top (40%), back (24%), left side (18%) and right side (18%) of the scalp for AA. Investigator determines the % scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total % scalp hair loss with a maximum score of 100. Score range from 0% (no scalp hair loss) to 100% (complete scalp hair loss), higher scores indicated more scalp hair loss. Percent change from baseline in SALT I is reported in terms of Least square mean and standard error.

  DB Treatment Period: Baseline (before dose on Day 1), Week 24

Secondary Outcomes (2)

• Change From Baseline in SALT I at Week 24: DB Treatment Period

  DBT Period: Baseline, Week 24

• Percentage of Participants Who Achieved Greater Than or Equal to (>=) 30%, >= 50% and >=75% Improvement From Baseline in SALT I at Week 24: DB Treatment Period

  DB Treatment Period: Baseline, Week 24

Other Outcomes (2)

• Number of Participants With Adverse Events (AE): DB Treatment Period

  DB Treatment Period: From first dosing date in DB up to (before the first dosing date in OLE) or (last dosing date + 4 weeks + 3 days), whichever is earlier (maximum up to 29 weeks)

• Number of Participants With Adverse Events: OLE Period

  OLE period: From first dosing date in OLE up to last dosing date + 4 weeks + 3 days (maximum up to 33 weeks)

Study Arms (3)

Etrasimod 2 mg

EXPERIMENTAL

Drug: Etrasimod

Etrasimod 3 mg

EXPERIMENTAL

Drug: Etrasimod

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Etrasimod DRUG

Etrasimod 2 mg tablet by mouth, once daily

Also known as: APD334

Etrasimod 2 mg

Placebo DRUG

Etrasimod matching placebo tablet by mouth, once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead
• Arena is a wholly owned subsidiary of Pfizer: collaborator

Study Sites (42)

Investigate MD

Scottsdale, Arizona, 85255, United States

Location

Dermatology Trial Associates

Bryant, Arkansas, 72022, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

University of California,Irvine

Irvine, California, 92697, United States

Location

Prospect Optometry

Lomita, California, 90717, United States

Location

Torrance Clinical Research Institute,Inc.

Lomita, California, 90717, United States

Location

Yale Eye Center

New Haven, Connecticut, 06511, United States

Location

Yale Investigational Drug Services

New Haven, Connecticut, 06511, United States

Location

Yale Center for Clinical Investigation

New Haven, Connecticut, 06519, United States

Location

Yale New Haven Hospital Department of Respiratory Care

New Haven, Connecticut, 06519, United States

Location

Advanced Sleep & Respiratory Institute, PA

Daytona Beach, Florida, 32117, United States

Location

International Eye Associates

Ormond Beach, Florida, 32174, United States

Location

Leavitt Medical Associates of Florida d/ba Ameriderm Research

Ormond Beach, Florida, 32174, United States

Location

Advanced Clinical Research Institute

Tampa, Florida, 33607, United States

Location

Advanced Medical Research PC

Sandy Springs, Georgia, 30328, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Eye Surgeons of Indiana

Indianapolis, Indiana, 46260, United States

Location

Magnante Eye Care (Ophthalmological Assessments)

Lafayette, Indiana, 47905, United States

Location

Physicians Research Group (Administrative Office Location)

Noblesville, Indiana, 46060, United States

Location

Physicians Research Group

West Lafayette, Indiana, 47906, United States

Location

Randall Dermatology, PC

West Lafayette, Indiana, 47906, United States

Location

Lawrence J. Green, MD LLC

Rockville, Maryland, 20850, United States

Location

Michigan Center for Skin Care Research

Clinton Township, Michigan, 48038, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

NYC Retina- Manhattan

New York, New York, 10003, United States

Location

Bobby Buka MD, PC

New York, New York, 10012, United States

Location

Rochester Ophthalmological Group

Rochester, New York, 14623, United States

Location

Skin Search of Rochester, Inc.

Rochester, New York, 14623, United States

Location

WDC Cosmetic and Research, PLLC

Wilmington, North Carolina, 28405, United States

Location

NW Dermatology Institute

Portland, Oregon, 97210, United States

Location

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Eye Center

Pittsburgh, Pennsylvania, 15213, United States

Location

International Clinical Research - Tennessee LLC

Murfreesboro, Tennessee, 37130, United States

Location

Progressive Clinical Research, PA

San Antonio, Texas, 78213, United States

Location

The Education & Research Foundation, Inc.

Lynchburg, Virginia, 24501, United States

Location

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

Location

PRINCIPLE RESEARCH SOLUTIONS (pulmonary function testing)

Spokane, Washington, 99204, United States

Location

SPOKANE EYE CLINIC (OCT and optical exam

Spokane, Washington, 99204, United States

Location

Dermatology Research Institute

Calgary, Alberta, T2J 7E1, Canada

Location

Laser Rejuvenation Clinics Edmonton D.T. Inc.

Edmonton, Alberta, T5J 3S9, Canada

Location

Innovaderm Research

Montreal, Quebec, H2X 2V1, Canada

Location

Related Publications (2)

• 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.

  PMID: 40145547 DERIVED

• 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.

  PMID: 39575597 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Alopecia Areata; Alopecia

Interventions

etrasimod

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-Blind, Placebo-Controlled

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 21, 2020
• Study Start: July 29, 2020
• Primary Completion: June 7, 2023
• Study Completion: June 7, 2023
• Last Updated: June 26, 2024
• Results First Posted: June 26, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (3); US (39)