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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Alopecia Areata

Treatments: Drug: Placebo; Drug: Etrasimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT04556734

APD334-205

C5041008 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 3 patient groups, including a placebo group

Etrasimod 2 mg

Experimental group

Treatment:

Drug: Etrasimod

Drug: Etrasimod

Etrasimod 3 mg

Experimental group

Treatment:

Drug: Etrasimod

Drug: Etrasimod

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo