Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE2) (EPIONE2)

April 23, 2024 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 multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

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
      • Hoover, Alabama, United States, 35244
        • Vanda Investigational Site
    • Arizona
      • Tempe, Arizona, United States, 85281
        • Vanda Investigational Site
    • California
      • Encino, California, United States, 91436
        • Vanda Investigational Site
      • Fountain Valley, California, United States, 92708
        • Vanda Investigational Site
      • Laguna Hills, California, United States, 92653
        • Vanda Investigational Site
      • Lomita, California, United States, 90717
        • Vanda Investigational Site
      • Los Angeles, California, United States, 90036
        • Vanda Investigational Site
      • Los Angeles, California, United States, 90025
        • Vanda Investigational Site
      • Los Angeles, California, United States, 90057
        • Vanda Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80220
        • Vanda Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • 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
      • Chicago, Illinois, United States, 60611
        • Vanda Investigational Site
      • 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
      • Timonium, Maryland, United States, 21093
        • 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
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Vanda Investigational Site
      • Hoboken, New Jersey, United States, 07030
        • Vanda Investigational Site
      • Verona, New Jersey, United States, 07044
        • Vanda Investigational Site
    • New York
      • Bronx, New York, United States, 10458
        • Vanda Investigational Site
      • Kew Gardens, New York, United States, 11415
        • 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
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • 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, 19103
        • 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
      • Spartanburg, South Carolina, United States, 29303
        • Vanda Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Vanda Investigational Site
      • Houston, Texas, United States, 77004
        • Vanda Investigational Site
      • Houston, Texas, United States, 77065
        • Vanda Investigational Site
      • Mesquite, Texas, United States, 75149
        • Vanda Investigational Site
    • Utah
      • South Jordan, Utah, United States, 84095
        • Vanda Investigational Site
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • Vanda Investigational Site
    • Virginia
      • Alexandria, Virginia, United States, 22311
        • Vanda Investigational Site
      • Newport News, Virginia, United States, 23606
        • Vanda Investigational Site
      • Norfolk, Virginia, United States, 23502
        • 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

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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
Experimental: Tradipitant
Oral Capsule
Drug: Tradipitant
BID
Placebo Comparator: Placebo
Oral Capsule
Drug: Placebo
BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2
Time Frame: 2 weeks
The WI-NRS responder is defined as a patient achieving at least 4 points reduction from baseline in weekly average of diary WI-NRS. Responses were measured on a scale of 0 - 10, with 0 being "no itch" and 10 being the "worst itch imaginable".
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability as measured by spontaneous reporting of adverse events (AEs)
Time Frame: 8 weeks
8 weeks
Improvement of disease severity in atopic dermatitis
Time Frame: 8 weeks
As rated by SCORing Atopic Dermatitis (SCORAD) index. Severity of atopic dermatitis will be measured on a scale from 0 (absent) to 103 (severe) over a period of 8 weeks.
8 weeks
Improvement of disease severity in atopic dermatitis
Time Frame: 8 weeks
As rated by the Eczema Area and Severity Index (EASI). Severity of atopic dermatitis will be measured on a scale from 0 (absent) to 72 (severe) over a period of 8 weeks.
8 weeks
Improvement of disease severity in atopic dermatitis
Time Frame: 8 weeks
As rated by the Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD). Severity of atopic dermatitis will be measured on a scale from 0 (absent) to 4 (severe) over a period of 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)

October 21, 2019

Primary Completion (Actual)

October 14, 2020

Study Completion (Actual)

October 14, 2020

Study Registration Dates

First Submitted

October 24, 2019

First Submitted That Met QC Criteria

October 24, 2019

First Posted (Actual)

October 28, 2019

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VLY-686-3102
  • EPIONE2 (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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