Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis

October 31, 2017 updated by: Vanda Pharmaceuticals

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • High Point, North Carolina, United States
      • Wilmington, North Carolina, United States
    • Texas
      • Pflugerville, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Oral
Drug: Placebo
Experimental: Tradipitant
Oral
Drug: Tradipitant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of tradipitant relative to placebo in reducing chronic pruritus as measured by the Visual Analogue Scale (VAS).
Time Frame: Starting at week 2.
Starting at week 2.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

January 6, 2016

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimate)

January 11, 2016

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

October 31, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VLY-686-2102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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