Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE2)

• Status: Recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanda Pharmaceuticals

Criteria

Inclusion Criteria:

• Male and non-pregnant, non-lactating female patients aged 18 - 70 years (inclusive);

• Diagnosed with atopic dermatitis;

• Suffering from chronic pruritus;

• Body Mass Index (BMI) of ≥18 and ≤40 kg/m2

Exclusion Criteria:

• Chronic pruritus due to condition other than atopic dermatitis (AD);

• A positive test for drugs of abuse at the screening or evaluation visits;

• Exposure to any investigational medication in the past 60 days