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

Phase 3TerminatedNCT04140695

Vanda Pharmaceuticals87 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

TradipitantDRUG

BID

PlaceboDRUG

BID

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (51)

Outcomes

Primary Outcomes

Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2

The WI-NRS responder is defined as a patient achieving at least 4 points reduction from baseline in weekly average of diary WI-NRS. Responses were measured on a scale of 0 - 10, with 0 being "no itch" and 10 being the "worst itch imaginable".

Time frame: 2 weeks

Data from ClinicalTrials.gov

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Vanda Investigational Site

Hoover, Alabama, United States

Vanda Investigational Site

Tempe, Arizona, United States

Vanda Investigational Site

Encino, California, United States

Vanda Investigational Site

Fountain Valley, California, United States

Vanda Investigational Site

Laguna Hills, California, United States

Vanda Investigational Site

Lomita, California, United States

Vanda Investigational Site

Los Angeles, California, United States

Vanda Investigational Site

Los Angeles, California, United States

Vanda Investigational Site

Los Angeles, California, United States

Vanda Investigational Site

Denver, Colorado, United States

...and 41 more locations