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

  • STATUS
    Recruiting
  • End date
    Oct 15, 2023
  • participants needed
    78
  • sponsor
    Arena Pharmaceuticals
Updated on 15 March 2022
areata alopecia

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).

Details
Condition Alopecia Areata
Treatment Placebo, Etrasimod
Clinical Study IdentifierNCT04556734
SponsorArena Pharmaceuticals
Last Modified on15 March 2022

Eligibility

Yes No Not Sure

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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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