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

CompletedPhase 2

Sponsor: Pfizer

Conditions: Alopecia Areata

Interventions: Etrasimod, Etrasimod, Placebo

Countries: United States, Canada

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 overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (42)

Scottsdale, Arizona, United States
Bryant, Arkansas, United States
Encinitas, California, United States
Fountain Valley, California, United States
Irvine, California, United States
Lomita, California, United States
Lomita, California, United States
New Haven, Connecticut, United States
New Haven, Connecticut, United States
New Haven, Connecticut, United States
New Haven, Connecticut, United States
Daytona Beach, Florida, United States
Ormond Beach, Florida, United States
Ormond Beach, Florida, United States
Tampa, Florida, United States
Sandy Springs, Georgia, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Lafayette, Indiana, United States
Noblesville, Indiana, United States
West Lafayette, Indiana, United States
West Lafayette, Indiana, United States
Rockville, Maryland, United States
Clinton Township, Michigan, United States
Saint Joseph, Missouri, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Rochester, New York, United States
Wilmington, North Carolina, United States
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