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

Phase 2

Completed

• Conditions: Alopecia Areata
• Interventions: Drug: Etrasimod; Drug: Placebo

• 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

Study Timeline

• Study Start: 2020-07-29
• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-21
• Primary Completion: 2023-06-07
• Study Completion: 2023-06-07
• Status Verified: 2024-05
• Results First Submitted: 2024-05-30
• Results First Submitted QC: 2024-05-30
• Last Update Submitted: 2024-05-30
• Results First Posted: 2024-06-26
• Last Update Posted: 2024-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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)

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

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