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

Alopecia Areata Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04556734
• Other study ID #: APD334-205
• Secondary ID: C5041008
• Status: Completed
• Phase: Phase 2
• Start date: July 29, 2020
• Est. completion date: June 7, 2023

Study information

• Verified date: July 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 7, 2023
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	Dermatology Research Institute	Calgary	Alberta
Canada	Laser Rejuvenation Clinics Edmonton D.T. Inc.	Edmonton	Alberta
Canada	Innovaderm Research	Montreal	Quebec
United States	Dermatology Trial Associates	Bryant	Arkansas
United States	Michigan Center for Skin Care Research	Clinton Township	Michigan
United States	Advanced Sleep & Respiratory Institute, PA	Daytona Beach	Florida
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	First OC Dermatology	Fountain Valley	California
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Eye Surgeons of Indiana	Indianapolis	Indiana
United States	University of California,Irvine	Irvine	California
United States	Magnante Eye Care (Ophthalmological Assessments)	Lafayette	Indiana
United States	Prospect Optometry	Lomita	California
United States	Torrance Clinical Research Institute,Inc.	Lomita	California
United States	The Education & Research Foundation, Inc.	Lynchburg	Virginia
United States	International Clinical Research - Tennessee LLC	Murfreesboro	Tennessee
United States	Yale Center for Clinical Investigation	New Haven	Connecticut
United States	Yale Eye Center	New Haven	Connecticut
United States	Yale Investigational Drug Services	New Haven	Connecticut
United States	Yale New Haven Hospital Department of Respiratory Care	New Haven	Connecticut
United States	Bobby Buka MD, PC	New York	New York
United States	NYC Retina- Manhattan	New York	New York
United States	Physicians Research Group (Administrative Office Location)	Noblesville	Indiana
United States	International Eye Associates	Ormond Beach	Florida
United States	Leavitt Medical Associates of Florida d/ba Ameriderm Research	Ormond Beach	Florida
United States	UPMC Department of Dermatology	Pittsburgh	Pennsylvania
United States	UPMC Eye Center	Pittsburgh	Pennsylvania
United States	NW Dermatology Institute	Portland	Oregon
United States	Rochester Ophthalmological Group	Rochester	New York
United States	Skin Search of Rochester, Inc.	Rochester	New York
United States	Lawrence J. Green, MD LLC	Rockville	Maryland
United States	MediSearch Clinical Trials	Saint Joseph	Missouri
United States	Progressive Clinical Research, PA	San Antonio	Texas
United States	Advanced Medical Research PC	Sandy Springs	Georgia
United States	Investigate MD	Scottsdale	Arizona
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	Advanced Clinical Research Institute	Tampa	Florida
United States	Physicians Research Group	West Lafayette	Indiana
United States	Randall Dermatology, PC	West Lafayette	Indiana
United States	WDC Cosmetic and Research, PLLC	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Arena is a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Severity of Alopecia Tool (SALT)		Baseline to Week 24
Secondary	Change From Baseline in SALT		Baseline to Week 24
Secondary	Proportion of Participants Achieving =30% Improvement From Baseline in SALT		Baseline to Week 24
Secondary	Proportion of Participants Achieving =50% Improvement From Baseline in SALT		Baseline to Week 24
Secondary	Proportion of Participants Achieving =75% Improvement From Baseline in SALT		Baseline to Week 24
Secondary	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.	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)

External Links

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