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

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

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).

Study Overview

• Status: Completed
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Etrasimod; Drug: Etrasimod; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Dermatology Research Institute
    • Edmonton, Alberta, Canada, T5J 3S9
      • Laser Rejuvenation Clinics Edmonton D.T. Inc.
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Innovaderm Research
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Investigate MD
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Dermatology Trial Associates
  • California
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Irvine, California, United States, 92697
      • University of California,Irvine
    • Lomita, California, United States, 90717
      • Prospect Optometry
    • Lomita, California, United States, 90717
      • Torrance Clinical Research Institute,Inc.
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale Center for Clinical Investigation
    • New Haven, Connecticut, United States, 06511
      • Yale Eye Center
    • New Haven, Connecticut, United States, 06511
      • Yale Investigational Drug Services
    • New Haven, Connecticut, United States, 06519
      • Yale New Haven Hospital Department of Respiratory Care
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Advanced Sleep & Respiratory Institute, PA
    • Ormond Beach, Florida, United States, 32174
      • International Eye Associates
    • Ormond Beach, Florida, United States, 32174
      • Leavitt Medical Associates of Florida d/ba Ameriderm Research
    • Tampa, Florida, United States, 33607
      • Advanced Clinical Research Institute
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Advanced Medical Research PC
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
    • Indianapolis, Indiana, United States, 46260
      • Eye Surgeons of Indiana
    • Lafayette, Indiana, United States, 47905
      • Magnante Eye Care (Ophthalmological Assessments)
    • Noblesville, Indiana, United States, 46060
      • Physicians Research Group (Administrative Office Location)
    • West Lafayette, Indiana, United States, 47906
      • Physicians Research Group
    • West Lafayette, Indiana, United States, 47906
      • Randall Dermatology, PC
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Lawrence J. Green, MD LLC
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Michigan Center for Skin Care Research
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • MediSearch Clinical Trials
  • New York
    • New York, New York, United States, 10003
      • NYC Retina- Manhattan
    • New York, New York, United States, 10012
      • Bobby Buka MD, PC
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester, Inc.
    • Rochester, New York, United States, 14623
      • Rochester Ophthalmological Group
  • North Carolina
    • Wilmington, North Carolina, United States, 28405
      • WDC Cosmetic and Research, PLLC
  • Oregon
    • Portland, Oregon, United States, 97210
      • NW Dermatology Institute
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Eye Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Department of Dermatology
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • International Clinical Research - Tennessee LLC
  • Texas
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research, PA
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • The Education & Research Foundation, Inc.
  • Washington
    • Spokane, Washington, United States, 99202
      • Dermatology Specialists of Spokane
    • Spokane, Washington, United States, 99204
      • PRINCIPLE RESEARCH SOLUTIONS (pulmonary function testing)
    • Spokane, Washington, United States, 99204
      • SPOKANE EYE CLINIC (OCT and optical exam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Etrasimod matching placebo tablet by mouth, once daily
Experimental: Etrasimod 2 mg	Drug: Etrasimod; Etrasimod 2 mg tablet by mouth, once daily; Other Names: APD334; Drug: Etrasimod; Etrasimod 3 mg (1 mg and 2 mg tablets) by mouth, once daily; Other Names: APD334
Experimental: Etrasimod 3 mg	Drug: Etrasimod; Etrasimod 2 mg tablet by mouth, once daily; Other Names: APD334; Drug: Etrasimod; Etrasimod 3 mg (1 mg and 2 mg tablets) by mouth, once daily; Other Names: APD334

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in 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. Change from baseline in SALT I is reported in terms of Least square mean and standard error.	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	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, back, and each side of the scalp for alopecia areata (AA). Investigator determine the percent 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 percent scalp hair loss with a maximum score of 100. Score range from 0 to 100, where 0 =no scalp hair loss to 100 = complete scalp hair loss, higher scores indicated more scalp hair loss. Percentage of participants who achieved >=30%, >=50%, >=75% improvement from baseline in SALT I at Week 24 was reported in this outcome measure.	DB Treatment Period: Baseline, Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AE): DB Treatment Period	An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations based on medical significance or any diagnosis of progressive multifocal leukoencephalopathy (PML). AEs included serious AEs and all non-SAEs.	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	An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations based on medical significance or any diagnosis of PML. AEs included serious AEs and all non-SAEs.	OLE period: From first dosing date in OLE up to last dosing date + 4 weeks + 3 days (maximum up to 33 weeks)

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Arena is a wholly owned subsidiary of Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2020
• Primary Completion (Actual): June 7, 2023
• Study Completion (Actual): June 7, 2023

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Alopecia; Etrasimod; APD334; Alopecia areata; Hair loss; T-cell-mediated autoimmune skin disorder
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: APD334-205; C5041008 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No