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

Primary Purpose

Alopecia Areata

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Etrasimod
Etrasimod
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring T-cell-mediated autoimmune skin disorder, Alopecia areata, Alopecia, APD334, Etrasimod, Hair loss

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigate MD
  • Dermatology Trial Associates
  • California Dermatology & Clinical Research Institute
  • First OC Dermatology
  • University of California,Irvine
  • Prospect Optometry
  • Torrance Clinical Research Institute,Inc.
  • Yale Eye Center
  • Yale Investigational Drug Services
  • Yale Center for Clinical Investigation
  • Yale New Haven Hospital Department of Respiratory Care
  • Advanced Sleep & Respiratory Institute, PA
  • International Eye Associates
  • Leavitt Medical Associates of Florida d/ba Ameriderm Research
  • Advanced Clinical Research Institute
  • Advanced Medical Research PC
  • Dawes Fretzin Clinical Research Group, LLC
  • Eye Surgeons of Indiana
  • Magnante Eye Care (Ophthalmological Assessments)
  • Physicians Research Group (Administrative Office Location)
  • Physicians Research Group
  • Randall Dermatology, PC
  • Lawrence J. Green, MD LLC
  • Michigan Center for Skin Care Research
  • MediSearch Clinical Trials
  • NYC Retina- Manhattan
  • Bobby Buka MD, PC
  • Rochester Ophthalmological Group
  • Skin Search of Rochester, Inc.
  • WDC Cosmetic and Research, PLLC
  • NW Dermatology Institute
  • UPMC Department of Dermatology
  • UPMC Eye Center
  • International Clinical Research - Tennessee LLC
  • Progressive Clinical Research, PA
  • The Education & Research Foundation, Inc.
  • Dermatology Specialists of Spokane
  • PRINCIPLE RESEARCH SOLUTIONS (pulmonary function testing)
  • SPOKANE EYE CLINIC (OCT and optical exam
  • Dermatology Research Institute
  • Laser Rejuvenation Clinics Edmonton D.T. Inc.
  • Innovaderm Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Etrasimod 2 mg

Etrasimod 3 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Severity of Alopecia Tool (SALT)

Secondary Outcome Measures

Change From Baseline in SALT
Proportion of Participants Achieving ≥30% Improvement From Baseline in SALT
Proportion of Participants Achieving ≥50% Improvement From Baseline in SALT
Proportion of Participants Achieving ≥75% Improvement From Baseline in SALT
Number and Severity of Adverse Events (Double-Blind Treatment Period and Open-Label Extension Period)
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.

Full Information

First Posted
September 15, 2020
Last Updated
July 11, 2023
Sponsor
Pfizer
Collaborators
Arena is a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04556734
Brief Title
Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 29, 2020 (Actual)
Primary Completion Date
June 7, 2023 (Actual)
Study Completion Date
June 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Arena is a wholly owned subsidiary of Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
T-cell-mediated autoimmune skin disorder, Alopecia areata, Alopecia, APD334, Etrasimod, Hair loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double-Blind, Placebo-Controlled
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Etrasimod 2 mg
Arm Type
Experimental
Arm Title
Etrasimod 3 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Etrasimod
Other Intervention Name(s)
APD334
Intervention Description
Etrasimod 2 mg tablet by mouth, once daily
Intervention Type
Drug
Intervention Name(s)
Etrasimod
Other Intervention Name(s)
APD334
Intervention Description
Etrasimod 3 mg (1 mg and 2 mg tablets) by mouth, once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Etrasimod matching placebo tablet by mouth, once daily
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Severity of Alopecia Tool (SALT)
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in SALT
Time Frame
Baseline to Week 24
Title
Proportion of Participants Achieving ≥30% Improvement From Baseline in SALT
Time Frame
Baseline to Week 24
Title
Proportion of Participants Achieving ≥50% Improvement From Baseline in SALT
Time Frame
Baseline to Week 24
Title
Proportion of Participants Achieving ≥75% Improvement From Baseline in SALT
Time Frame
Baseline to Week 24
Title
Number and Severity of Adverse Events (Double-Blind Treatment Period and Open-Label Extension Period)
Description
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Investigate MD
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
Dermatology Trial Associates
City
Bryant
State/Province
Arkansas
ZIP/Postal Code
72022
Country
United States
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
University of California,Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Prospect Optometry
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Torrance Clinical Research Institute,Inc.
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Yale Eye Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Yale Investigational Drug Services
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Yale Center for Clinical Investigation
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Yale New Haven Hospital Department of Respiratory Care
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Advanced Sleep & Respiratory Institute, PA
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
International Eye Associates
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Leavitt Medical Associates of Florida d/ba Ameriderm Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Advanced Medical Research PC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Eye Surgeons of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Magnante Eye Care (Ophthalmological Assessments)
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Physicians Research Group (Administrative Office Location)
City
Noblesville
State/Province
Indiana
ZIP/Postal Code
46060
Country
United States
Facility Name
Physicians Research Group
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47906
Country
United States
Facility Name
Randall Dermatology, PC
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47906
Country
United States
Facility Name
Lawrence J. Green, MD LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Michigan Center for Skin Care Research
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
MediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
NYC Retina- Manhattan
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Bobby Buka MD, PC
City
New York
State/Province
New York
ZIP/Postal Code
10012
Country
United States
Facility Name
Rochester Ophthalmological Group
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Skin Search of Rochester, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
WDC Cosmetic and Research, PLLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28405
Country
United States
Facility Name
NW Dermatology Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
UPMC Department of Dermatology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Eye Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
International Clinical Research - Tennessee LLC
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Progressive Clinical Research, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
The Education & Research Foundation, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Dermatology Specialists of Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
PRINCIPLE RESEARCH SOLUTIONS (pulmonary function testing)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
SPOKANE EYE CLINIC (OCT and optical exam
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Dermatology Research Institute
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Facility Name
Laser Rejuvenation Clinics Edmonton D.T. Inc.
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5J 3S9
Country
Canada
Facility Name
Innovaderm Research
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=APD334-205
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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