Clinical trial NCT04556734: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alopecia Areata
Keywords: T-cell-mediated autoimmune skin disorder
Alopecia areata
Alopecia
APD334
Etrasimod
Hair loss
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Arena is a wholly owned subsidiary of Pfizer
First posted: 2020-09-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-Blind, Placebo-Controlled
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Percent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment Period
timeFrame: DB Treatment Period: Baseline (before dose on Day 1), Week 24
Secondary outcomes:
measure: Change From Baseline in SALT I at Week 24: DB Treatment Period
timeFrame: DBT Period: Baseline, Week 24
measure: 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
timeFrame: DB Treatment Period: Baseline, Week 24
Other outcomes:
measure: Number of Participants With Adverse Events (AE): DB Treatment Period
timeFrame: 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)
measure: Number of Participants With Adverse Events: OLE Period
timeFrame: OLE period: From first dosing date in OLE up to last dosing date + 4 weeks + 3 days (maximum up to 33 weeks)
Locations:
city: Scottsdale
country: United States
facility: Investigate MD
state: Arizona
city: Bryant
country: United States
facility: Dermatology Trial Associates
state: Arkansas
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Irvine
country: United States
facility: University of California,Irvine
state: California
city: Lomita
country: United States
facility: Prospect Optometry
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research Institute,Inc.
state: California
city: New Haven
country: United States
facility: Yale Eye Center
state: Connecticut
city: New Haven
country: United States
facility: Yale Investigational Drug Services
state: Connecticut
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital Department of Respiratory Care
state: Connecticut
city: Daytona Beach
country: United States
facility: Advanced Sleep & Respiratory Institute, PA
state: Florida
city: Ormond Beach
country: United States
facility: International Eye Associates
state: Florida
city: Ormond Beach
country: United States
facility: Leavitt Medical Associates of Florida d/ba Ameriderm Research
state: Florida
city: Tampa
country: United States
facility: Advanced Clinical Research Institute
state: Florida
city: Sandy Springs
country: United States
facility: Advanced Medical Research PC
state: Georgia
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Eye Surgeons of Indiana
state: Indiana
city: Lafayette
country: United States
facility: Magnante Eye Care (Ophthalmological Assessments)
state: Indiana
city: Noblesville
country: United States
facility: Physicians Research Group (Administrative Office Location)
state: Indiana
city: West Lafayette
country: United States
facility: Physicians Research Group
state: Indiana
city: West Lafayette
country: United States
facility: Randall Dermatology, PC
state: Indiana
city: Rockville
country: United States
facility: Lawrence J. Green, MD LLC
state: Maryland
city: Clinton Township
country: United States
facility: Michigan Center for Skin Care Research
state: Michigan
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: New York
country: United States
facility: NYC Retina- Manhattan
state: New York
city: New York
country: United States
facility: Bobby Buka MD, PC
state: New York
city: Rochester
country: United States
facility: Rochester Ophthalmological Group
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc.
state: New York
city: Wilmington
country: United States
facility: WDC Cosmetic and Research, PLLC
state: North Carolina
city: Portland
country: United States
facility: NW Dermatology Institute
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Department of Dermatology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Eye Center
state: Pennsylvania
city: Murfreesboro
country: United States
facility: International Clinical Research - Tennessee LLC
state: Tennessee
city: San Antonio
country: United States
facility: Progressive Clinical Research, PA
state: Texas
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc.
state: Virginia
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane
state: Washington
city: Spokane
country: United States
facility: PRINCIPLE RESEARCH SOLUTIONS (pulmonary function testing)
state: Washington
city: Spokane
country: United States
facility: SPOKANE EYE CLINIC (OCT and optical exam
state: Washington
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
city: Edmonton
country: Canada
facility: Laser Rejuvenation Clinics Edmonton D.T. Inc.
state: Alberta
city: Montreal
country: Canada
facility: Innovaderm Research
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: