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Completed

NCT Number: NCT04556734

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

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).

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Key information

Conditions

Alopecia Areata Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dermatology Research Institute, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Etrasimod

Drug

Etrasimod 2 mg tablet by mouth, once daily

Other names: APD334

Placebo

Drug

Etrasimod matching placebo tablet by mouth, once daily

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. 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

    Time frame: 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.

Other outcomes

  1. Number of Participants With Adverse Events (AE): DB Treatment Period

    Time frame: 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)

    An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations based on medical significance or any diagnosis of progressive multifocal leukoencephalopathy (PML). AEs included serious AEs and all non-SAEs.

  2. Number of Participants With Adverse Events: OLE Period

    Time frame: OLE period: From first dosing date in OLE up to last dosing date + 4 weeks + 3 days (maximum up to 33 weeks)

    An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations based on medical significance or any diagnosis of PML. AEs included serious AEs and all non-SAEs.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Arena is a wholly owned subsidiary of Pfizer

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2020
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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