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

Pfizer80 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Alopecia Areata

Interventions

EtrasimodDRUG

Etrasimod 2 mg tablet by mouth, once daily

EtrasimodDRUG

Etrasimod 3 mg (1 mg and 2 mg tablets) by mouth, once daily

PlaceboDRUG

Etrasimod matching placebo tablet by mouth, once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Percent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment Period

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.

Time frame: DB Treatment Period: Baseline (before dose on Day 1), Week 24

Secondary Outcomes

Change From Baseline in SALT I at Week 24: DB Treatment Period

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.

Time frame: DBT Period: Baseline, Week 24

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

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.

Data from ClinicalTrials.gov

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Investigate MD

Scottsdale, Arizona, United States

Dermatology Trial Associates

Bryant, Arkansas, United States

California Dermatology & Clinical Research Institute

Encinitas, California, United States

First OC Dermatology

Fountain Valley, California, United States

University of California,Irvine

Irvine, California, United States

Prospect Optometry

Lomita, California, United States

Torrance Clinical Research Institute,Inc.

Lomita, California, 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

...and 32 more locations