A Randomized, Double-blind, Placebo-controlled, Efficacy Study of the Neurokinin-1 Receptor Antagonist VLY-686 in Patients With Atopic Dermatitis

Purpose:

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

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

Study is Available At:

Original ID:

VP-VLY-686-3102

NCT ID:

NCT04140695

Secondary ID:

Study Acronym:

EPIONE2

Brief Title:

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

Official Title:

A Randomized, Double-blind, Placebo-controlled, Efficacy Study of the Neurokinin-1 Receptor Antagonist VLY-686 in Patients With Atopic Dermatitis

ClinicalTrials.gov Link:

https://clinicaltrials.gov/show/NCT04140695

Overall Status:

Completed

Study Phase:

Phase 3

Genders:

N/A

Minimum Age:

18 Years

Maximum Age:

70 Years

Study Source:

Vanda Pharmaceuticals

Oversight Authority:

There was an error processing this request

Reasons Why Stopped:

Study Type:

Interventional

Study Design:

Number of Arms:

2

Number of Groups:

0

Total Enrollment:

87

Enrollment Type:

Actual

Data Source: ClinicalTrials.gov

Date Processed: February 07, 2023

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