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

April 24, 2020 updated by: Vanda Pharmaceuticals

A Randomized, Double-Blind, Placebo-Controlled Efficacy Study of The Neurokinin-1 Receptor Antagonist VLY-686 in Patients With Atopic Dermatitis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

375

Phase

  • Phase 3

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
    • Alabama
      • Birmingham, Alabama, United States, 35224
        • Vanda Investigational Site
      • Birmingham, Alabama, United States, 35233
        • Vanda Investigational Site
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Vanda Investigational Site
    • California
      • Encino, California, United States, 91436
        • Vanda Investigational Site
      • Fountain Valley, California, United States, 92708
        • Vanda Investigational Site
      • Fremont, California, United States, 94538
        • Vanda Investigational Site
      • Laguna Hills, California, United States, 92653
        • Vanda Investigational Site
      • Lomita, California, United States, 90717
        • Vanda Investigational Site
      • Long Beach, California, United States, 90806
        • Vanda Investigational Site
      • Los Angeles, California, United States, 90017
        • Vanda Investigational Site
      • Los Angeles, California, United States, 90036
        • Vanda Investigational Site
      • San Diego, California, United States, 92122
        • Vanda Investigational Site
      • Santa Monica, California, United States, 90404
        • Vanda Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80220
        • Vanda Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • Vanda Investigational Site
      • Hialeah, Florida, United States, 33016
        • Vanda Investigational Site
      • Miami, Florida, United States, 33126
        • Vanda Investigational Site
      • Tampa, Florida, United States, 33613
        • Vanda Investigational Site
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Vanda Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83704
        • Vanda Investigational Site
    • Illinois
      • Normal, Illinois, United States, 61761
        • Vanda Investigational Site
      • Skokie, Illinois, United States, 60077
        • Vanda Investigational Site
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • Vanda Investigational Site
    • Louisiana
      • Crowley, Louisiana, United States, 70526
        • Vanda Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Vanda Investigational Site
      • Towson, Maryland, United States, 21204
        • Vanda Investigational Site
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Vanda Investigational Site
      • Brighton, Massachusetts, United States, 02135
        • Vanda Investigational Site
    • Michigan
      • Fort Gratiot, Michigan, United States, 48059
        • Vanda Investigational Site
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • Vanda Investigational Site
      • Saint Louis, Missouri, United States, 63141
        • Vanda Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Vanda Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Vanda Investigational Site
      • Las Vegas, Nevada, United States, 89106
        • Vanda Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Vanda Investigational Site
      • Verona, New Jersey, United States, 07044
        • Vanda Investigational Site
    • New York
      • Brooklyn, New York, United States, 11201
        • Vanda Investigational Site
      • New York, New York, United States, 10003
        • Vanda Investigational Site
      • New York, New York, United States, 10022
        • Vanda Investigational Site
      • New York, New York, United States, 10075
        • Vanda Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Vanda Investigational Site
      • High Point, North Carolina, United States, 27262
        • Vanda Investigational Site
      • Wilmington, North Carolina, United States, 28405
        • Vanda Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Vanda Investigational Site
      • Dayton, Ohio, United States, 45414
        • Vanda Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Vanda Investigational Site
      • Tulsa, Oklahoma, United States, 74136
        • Vanda Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Vanda Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Vanda Investigational Site
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Vanda Investigational Site
    • South Carolina
      • Spartanburg, South Carolina, United States, 29301
        • Vanda Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Vanda Investigational Site
      • Nashville, Tennessee, United States, 37211
        • Vanda Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Vanda Investigational Site
      • Pflugerville, Texas, United States, 78660
        • Vanda Investigational Site
      • San Antonio, Texas, United States, 78213
        • Vanda Investigational Site
      • San Antonio, Texas, United States, 78218
        • Vanda Investigational Site
    • Utah
      • West Jordan, Utah, United States, 84088
        • Vanda Investigational Site
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • Vanda Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Vanda Investigational Site
      • Norfolk, Virginia, United States, 23507
        • Vanda Investigational Site
      • Richmond, Virginia, United States, 23233
        • Vanda Investigational Site
    • Washington
      • 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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
Drug: Placebo
Oral Capsule
Experimental: Tradipitant
Drug: Tradipitant
Oral Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of worst itch in atopic dermatitis
Time Frame: 8 weeks
As measured by Numerical Rating Scale (NRS)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of disease severity in atopic dermatitis
Time Frame: 8 weeks
As measured by SCORing Atopic Dermatitis (SCORAD) index
8 weeks
Improvement of disease severity in atopic dermatitis
Time Frame: 8 weeks
As measured by Eczema Area and Severity Index (EASI)
8 weeks
Improvement of disease severity in atopic dermatitis
Time Frame: 8 weeks
As measured by Investigator Global Assessment for Atopic Dermatitis (IGA-AD)
8 weeks
Safety and tolerability as measured by spontaneous reporting of adverse events (AEs)
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

Vanda Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

June 30, 2018

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

June 13, 2018

First Submitted That Met QC Criteria

June 13, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 24, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VLY-686-3101
  • EPIONE (Other Identifier: Vanda Pharmaceuticals, Inc.)

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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