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

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Brief Title

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

Official 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

Brief Summary

      The purpose of this study is to evaluate the safety and efficacy of etrasimod monotherapy (2
      milligrams [mg]) in participants with moderate-to-severe alopecia areata.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Percent Change From Baseline in Severity of Alopecia Tool (SALT)

Secondary Outcome

 Change From Baseline in SALT

Condition

Alopecia Areata

Intervention

Etrasimod

Study Arms / Comparison Groups

 Etrasimod 2 mg
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

36

Start Date

August 31, 2020

Completion Date

June 2022

Primary Completion Date

December 2021

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 (AA) as assessed by a SALT score of ≥50

          -  Current episode of hair loss for ≥6 months but <8 years

          -  Stable disease condition (ie, no significant growth or loss 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 an oral Janus kinase (JAK) inhibitor, including participation in
             clinical studies of JAK inhibitors
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Arena CT.gov Administrator, +1 855-218-9153, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT04556734

Organization ID

APD334-205


Responsible Party

Sponsor

Study Sponsor

Arena Pharmaceuticals


Study Sponsor

Arena CT.gov Administrator, Study Director, Arena Pharmaceuticals


Verification Date

September 2020