Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis

Vanda Pharmaceuticals168 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

168

Conditions

Atopic Dermatitis

Interventions

TradipitantDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and non-pregnant, non-lactating female subjects aged 18 - 65 years (inclusive) * Diagnosed with atopic dermatitis * Suffering from chronic pruritus with pruritus being actively present Exclusion Criteria: * Chronic pruritus due to condition other than atopic dermatitis (AD) * Participation in a previous tradipitant (LY686017 or VLY-686) trial * Anyone affiliated with the site or sponsor and/or anyone who may consent under duress * Any other sound medical reason as determined by the Investigator including any condition which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance or may confound study results

Locations (28)

Outcomes

Primary Outcomes

Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score

Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left endpoint was marked "no itch" (0 mm) and in the right endpoint was marked "worst imaginable itch" (100 mm).

Time frame: 56 days

Data from ClinicalTrials.gov

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Vanda Investigational Site

Encinitas, California, United States

Vanda Investigational Site

Encino, California, United States

Vanda Investigational Site

Lomita, California, United States

Vanda Investigational Site

San Diego, California, United States

Vanda Investigational Site

San Diego, California, United States

Vanda Investigational Site

Miami, Florida, United States

Vanda Investigational Site

Miami, Florida, United States

Vanda Investigational Site

Ormond Beach, Florida, United States

Vanda Investigational Site

Columbus, Georgia, United States

Vanda Investigational Site

Plainfield, Indiana, United States

...and 18 more locations