Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanda Investigational Site, Encinitas, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tradipitant

Drug

Placebo

Drug

Primary outcomes

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

Time frame: 56 days

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).

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jan 11, 2016
Registry last updated: Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed