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

NCT ID: NCT04140695

Last Updated: 2024-05-14

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-21

Study Completion Date

2020-10-14

Brief Summary

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

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tradipitant

Oral Capsule

Group Type EXPERIMENTAL

Tradipitant

Intervention Type DRUG

BID

Placebo

Oral Capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

BID

Interventions

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Tradipitant

BID

Intervention Type DRUG

Placebo

BID

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanda Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vanda Investigational Site

Hoover, Alabama, United States

Site Status

Vanda Investigational Site

Tempe, Arizona, United States

Site Status

Vanda Investigational Site

Encino, California, United States

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Vanda Investigational Site

Fountain Valley, California, United States

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Vanda Investigational Site

Laguna Hills, California, United States

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Vanda Investigational Site

Lomita, California, United States

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Vanda Investigational Site

Los Angeles, California, United States

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Vanda Investigational Site

Los Angeles, California, United States

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Vanda Investigational Site

Los Angeles, California, United States

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Vanda Investigational Site

Denver, Colorado, United States

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Vanda Investigational Site

Clearwater, Florida, United States

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Vanda Investigational Site

Miami, Florida, United States

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Vanda Investigational Site

Tampa, Florida, United States

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Vanda Investigational Site

Savannah, Georgia, United States

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Vanda Investigational Site

Boise, Idaho, United States

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Vanda Investigational Site

Chicago, Illinois, United States

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Vanda Investigational Site

Normal, Illinois, United States

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Vanda Investigational Site

Skokie, Illinois, United States

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Vanda Investigational Site

Plainfield, Indiana, United States

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Vanda Investigational Site

Crowley, Louisiana, United States

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Vanda Investigational Site

Timonium, Maryland, United States

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Vanda Investigational Site

Fort Gratiot, Michigan, United States

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Vanda Investigational Site

Saint Joseph, Missouri, United States

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Vanda Investigational Site

St Louis, Missouri, United States

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Vanda Investigational Site

Omaha, Nebraska, United States

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Vanda Investigational Site

Las Vegas, Nevada, United States

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Vanda Investigational Site

Berlin, New Jersey, United States

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Vanda Investigational Site

Hoboken, New Jersey, United States

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Vanda Investigational Site

Verona, New Jersey, United States

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Vanda Investigational Site

Kew Gardens, New York, United States

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Vanda Investigational Site

New York, New York, United States

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Vanda Investigational Site

New York, New York, United States

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Vanda Investigational Site

The Bronx, New York, United States

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Vanda Investigational Site

Charlotte, North Carolina, United States

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Vanda Investigational Site

Cincinnati, Ohio, United States

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Vanda Investigational Site

Oklahoma City, Oklahoma, United States

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Vanda Investigational Site

Tulsa, Oklahoma, United States

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Vanda Investigational Site

Philadelphia, Pennsylvania, United States

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Vanda Investigational Site

Johnston, Rhode Island, United States

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Vanda Investigational Site

Spartanburg, South Carolina, United States

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Vanda Investigational Site

Spartanburg, South Carolina, United States

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Vanda Investigational Site

Dallas, Texas, United States

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Vanda Investigational Site

Houston, Texas, United States

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Vanda Investigational Site

Houston, Texas, United States

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Vanda Investigational Site

Mesquite, Texas, United States

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Vanda Investigational Site

South Jordan, Utah, United States

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Vanda Investigational Site

South Burlington, Vermont, United States

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Vanda Investigational Site

Alexandria, Virginia, United States

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Vanda Investigational Site

Newport News, Virginia, United States

Site Status

Vanda Investigational Site

Norfolk, Virginia, United States

Site Status

Vanda Investigational Site

Spokane, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://advandastudy.com

Study Webpage

Other Identifiers

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EPIONE2

Identifier Type: OTHER

Identifier Source: secondary_id

VP-VLY-686-3102

Identifier Type: -

Identifier Source: org_study_id

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