Overview

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