Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis

May 17, 2024 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
    • California
      • Encinitas, California, United States, 92024
        • Vanda Investigational Site
      • Encino, California, United States, 91436
        • Vanda Investigational Site
      • Lomita, California, United States, 90717
        • Vanda Investigational Site
      • San Diego, California, United States, 92122
        • Vanda Investigational Site
      • San Diego, California, United States, 92123
        • Vanda Investigational Site
    • Florida
      • Miami, Florida, United States, 33126
        • Vanda Investigational Site
      • Miami, Florida, United States, 33136
        • Vanda Investigational Site
      • Ormond Beach, Florida, United States, 32174
        • Vanda Investigational Site
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Vanda Investigational Site
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • Vanda Investigational Site
    • Louisiana
      • Crowley, Louisiana, United States, 70526
        • Vanda Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Vanda Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Vanda Investigational Site
    • New York
      • New York, New York, United States, 10022
        • Vanda Investigational Site
      • New York, New York, United States, 10075
        • Vanda Investigational Site
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Vanda Investigational Site
      • Wilmington, North Carolina, United States, 28405
        • Vanda Investigational Site
      • Winston-Salem, North Carolina, United States, 27104
        • Vanda Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Vanda Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Vanda Investigational Site
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Vanda Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Vanda Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Vanda Investigational Site
      • Pflugerville, Texas, United States, 78660
        • Vanda Investigational Site
      • San Antonio, Texas, United States, 78218
        • Vanda Investigational Site
    • Utah
      • West Jordan, Utah, United States, 84088
        • Vanda Investigational Site
    • Washington
      • Seattle, Washington, United States, 98101
        • Vanda Investigational Site
      • Spokane, Washington, United States, 99202
        • Vanda Investigational Site

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

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
Measure Description
Time Frame
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).
56 days

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 (Actual)

January 19, 2016

Primary Completion (Actual)

August 4, 2017

Study Completion (Actual)

August 4, 2017

Study Registration Dates

First Submitted

January 6, 2016

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimated)

January 11, 2016

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VLY-686-2102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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