A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis (ADVISE)

Arena Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Etrasimod 1 mg; Drug: Etrasimod 2 mg; Drug: Etrasimod matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04162769

APD334-201

Details and patient eligibility

About

The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderate-to-severe atopic dermatitis (AD).

Enrollment: 140 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with chronic atopic dermatitis, defined by Hanifin and Rajka criteria, that has been present for at least 1 year prior to the Screening Visit
• Participants with Eczema Area and Severity Index (EASI) ≥ 12 at the Screening Visit and ≥ 16 at the Baseline Visit
• Participants with validated Investigator's Global Assessment (vIGA) score ≥ 3 (on the 0 to 4 vIGA scale, in which 3 = moderate and 4 = severe) involvement at the Screening and Baseline visits

Exclusion criteria

• Presence of skin comorbidities that would interfere with study assessments of the underlying disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 4 patient groups, including a placebo group

12-Week Double-Blind Treatment Period: Etrasimod 1 milligrams (mg)

Experimental group

Treatment:

Drug: Etrasimod 1 mg

12-Week Double-Blind Treatment Period: Etrasimod 2 mg

Experimental group

Treatment:

Drug: Etrasimod 2 mg

12-Week Double-Blind Treatment Period: Placebo

Placebo Comparator group

Treatment:

Drug: Etrasimod matching placebo

52-Week Open-Label Extension Period: Etrasimod 2 mg

Experimental group

Treatment:

Drug: Etrasimod 2 mg