Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata
- Registration Number
- NCT04556734
- Lead Sponsor
- Pfizer
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Etrasimod 2 mg Etrasimod - Etrasimod 3 mg Etrasimod - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment Period DB Treatment Period: Baseline (before dose on Day 1), Week 24 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in SALT I at Week 24: DB Treatment Period DBT Period: Baseline, Week 24 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.
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 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.
Trial Locations
- Locations (42)
UPMC Department of Dermatology
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Eye Center
🇺🇸Pittsburgh, Pennsylvania, United States
Investigate MD
🇺🇸Scottsdale, Arizona, United States
Prospect Optometry
🇺🇸Lomita, California, United States
University of California,Irvine
🇺🇸Irvine, California, United States
First OC Dermatology
🇺🇸Fountain Valley, California, United States
California Dermatology & Clinical Research Institute
🇺🇸Encinitas, California, United States
Dermatology Trial Associates
🇺🇸Bryant, Arkansas, United States
Torrance Clinical Research Institute,Inc.
🇺🇸Lomita, California, United States
International Eye Associates
🇺🇸Ormond Beach, Florida, United States
Advanced Sleep & Respiratory Institute, PA
🇺🇸Daytona Beach, Florida, United States
Leavitt Medical Associates of Florida d/ba Ameriderm Research
🇺🇸Ormond Beach, Florida, United States
Magnante Eye Care (Ophthalmological Assessments)
🇺🇸Lafayette, Indiana, United States
Advanced Medical Research PC
🇺🇸Sandy Springs, Georgia, United States
Physicians Research Group (Administrative Office Location)
🇺🇸Noblesville, Indiana, United States
Physicians Research Group
🇺🇸West Lafayette, Indiana, United States
Randall Dermatology, PC
🇺🇸West Lafayette, Indiana, United States
Michigan Center for Skin Care Research
🇺🇸Clinton Township, Michigan, United States
NYC Retina- Manhattan
🇺🇸New York, New York, United States
Rochester Ophthalmological Group
🇺🇸Rochester, New York, United States
WDC Cosmetic and Research, PLLC
🇺🇸Wilmington, North Carolina, United States
Bobby Buka MD, PC
🇺🇸New York, New York, United States
Skin Search of Rochester, Inc.
🇺🇸Rochester, New York, United States
International Clinical Research - Tennessee LLC
🇺🇸Murfreesboro, Tennessee, United States
Dermatology Specialists of Spokane
🇺🇸Spokane, Washington, United States
The Education & Research Foundation, Inc.
🇺🇸Lynchburg, Virginia, United States
PRINCIPLE RESEARCH SOLUTIONS (pulmonary function testing)
🇺🇸Spokane, Washington, United States
SPOKANE EYE CLINIC (OCT and optical exam
🇺🇸Spokane, Washington, United States
Dermatology Research Institute
🇨🇦Calgary, Alberta, Canada
Laser Rejuvenation Clinics Edmonton D.T. Inc.
🇨🇦Edmonton, Alberta, Canada
Innovaderm Research
🇨🇦Montreal, Quebec, Canada
MediSearch Clinical Trials
🇺🇸Saint Joseph, Missouri, United States
Yale Eye Center
🇺🇸New Haven, Connecticut, United States
Yale Investigational Drug Services
🇺🇸New Haven, Connecticut, United States
Yale Center for Clinical Investigation
🇺🇸New Haven, Connecticut, United States
Yale New Haven Hospital Department of Respiratory Care
🇺🇸New Haven, Connecticut, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Advanced Clinical Research Institute
🇺🇸Tampa, Florida, United States
Progressive Clinical Research, PA
🇺🇸San Antonio, Texas, United States
NW Dermatology Institute
🇺🇸Portland, Oregon, United States
Eye Surgeons of Indiana
🇺🇸Indianapolis, Indiana, United States
Lawrence J. Green, MD LLC
🇺🇸Rockville, Maryland, United States