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

NCT03568331 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: VP-VLY-686-3101EPIONE
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 70

Brief Summary

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

Conditions

Atopic Dermatitis

Keywords

Chronic Pruritus; Eczema

Outcome Measures

Primary Outcomes (1)

• Reduction of Worst Itch in Atopic Dermatitis

  Reduction of worst itch in atopic dermatitis as measured by Numerical Rating Scale (NRS). Worst Itch NRS is an assessment tool that is used to report the maximum intensity of participant's itch during a 24-hour recall period. Participants were asked the following question: Please rate the itching severity that describes your worst level of itching in the past 24 hours \[0=No Itch, 10=Worst Itch Imaginable\].

  8 weeks

Secondary Outcomes (2)

• Improvement of Disease Severity in Atopic Dermatitis

  8 weeks

• Proportion of Patients With Improvement on Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of at Least 2-point Reduction

  8 weeks

Study Arms (2)

Tradipitant

EXPERIMENTAL

Drug: Tradipitant

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tradipitant DRUG

Oral Capsule

Tradipitant

Placebo DRUG

Oral Capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 8 weeks

Sponsors & Collaborators

• Vanda Pharmaceuticals: lead

Study Sites (70)

Vanda Investigational Site

Birmingham, Alabama, 35224, United States

Location

Vanda Investigational Site

Birmingham, Alabama, 35233, United States

Location

Vanda Investigational Site

Tempe, Arizona, 85283, United States

Location

Vanda Investigational Site

Encino, California, 91436, United States

Location

Vanda Investigational Site

Fountain Valley, California, 92708, United States

Location

Vanda Investigational Site

Fremont, California, 94538, United States

Location

Vanda Investigational Site

Laguna Hills, California, 92653, United States

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Vanda Investigational Site

Lomita, California, 90717, United States

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Vanda Investigational Site

Long Beach, California, 90806, United States

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Vanda Investigational Site

Los Angeles, California, 90017, United States

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Vanda Investigational Site

Los Angeles, California, 90036, United States

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Vanda Investigational Site

San Diego, California, 92122, United States

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Vanda Investigational Site

Santa Monica, California, 90404, United States

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Vanda Investigational Site

Denver, Colorado, 80220, United States

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Vanda Investigational Site

Aventura, Florida, 33180, United States

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Vanda Investigational Site

Clearwater, Florida, 33756, United States

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Vanda Investigational Site

Fort Lauderdale, Florida, 33306, United States

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Vanda Investigational Site

Hialeah, Florida, 33016, United States

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Vanda Investigational Site

Miami, Florida, 33126, United States

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Vanda Investigational Site

Miami, Florida, 33137, United States

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Vanda Investigational Site

Miramar, Florida, 33027, United States

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Vanda Investigational Site

Ormond Beach, Florida, 32174, United States

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Vanda Investigational Site

South Miami, Florida, 33143, United States

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Vanda Investigational Site

Tampa, Florida, 33613, United States

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Vanda Investigational Site

Savannah, Georgia, 31406, United States

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Vanda Investigational Site

Boise, Idaho, 83704, United States

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Vanda Investigational Site

Normal, Illinois, 61761, United States

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Vanda Investigational Site

Skokie, Illinois, 60077, United States

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Vanda Investigational Site

Plainfield, Indiana, 46168, United States

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Vanda Investigational Site

Crowley, Louisiana, 70526, United States

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Vanda Investigational Site

Rockville, Maryland, 20850, United States

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Vanda Investigational Site

Towson, Maryland, 21204, United States

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Vanda Investigational Site

Beverly, Massachusetts, 01915, United States

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Vanda Investigational Site

Brighton, Massachusetts, 02135, United States

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Vanda Investigational Site

Fort Gratiot, Michigan, 48059, United States

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Vanda Investigational Site

Saint Joseph, Missouri, 64506, United States

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Vanda Investigational Site

St Louis, Missouri, 63141, United States

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Vanda Investigational Site

Omaha, Nebraska, 68144, United States

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Vanda Investigational Site

Las Vegas, Nevada, 89106, United States

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Vanda Investigational Site

Las Vegas, Nevada, 89119, United States

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Vanda Investigational Site

Berlin, New Jersey, 08009, United States

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Vanda Investigational Site

Verona, New Jersey, 07044, United States

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Vanda Investigational Site

Brooklyn, New York, 11201, United States

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Vanda Investigational Site

New York, New York, 10003, United States

Location

Vanda Investigational Site

New York, New York, 10022, United States

Location

Vanda Investigational Site

New York, New York, 10075, United States

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Vanda Investigational Site

Charlotte, North Carolina, 28277, United States

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Vanda Investigational Site

High Point, North Carolina, 27262, United States

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Vanda Investigational Site

Wilmington, North Carolina, 28405, United States

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Vanda Investigational Site

Cincinnati, Ohio, 45212, United States

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Vanda Investigational Site

Dayton, Ohio, 45414, United States

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Vanda Investigational Site

Oklahoma City, Oklahoma, 73112, United States

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Vanda Investigational Site

Tulsa, Oklahoma, 74136, United States

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Vanda Investigational Site

Philadelphia, Pennsylvania, 19104, United States

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Vanda Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

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Vanda Investigational Site

Johnston, Rhode Island, 02919, United States

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Vanda Investigational Site

North Charleston, South Carolina, 29420, United States

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Vanda Investigational Site

Spartanburg, South Carolina, 29301, United States

Location

Vanda Investigational Site

Chattanooga, Tennessee, 37421, United States

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Vanda Investigational Site

Nashville, Tennessee, 37211, United States

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Vanda Investigational Site

Dallas, Texas, 75230, United States

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Vanda Investigational Site

Pflugerville, Texas, 78660, United States

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Vanda Investigational Site

San Antonio, Texas, 78213, United States

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Vanda Investigational Site

San Antonio, Texas, 78218, United States

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Vanda Investigational Site

West Jordan, Utah, 84088, United States

Location

Vanda Investigational Site

South Burlington, Vermont, 05403, United States

Location

Vanda Investigational Site

Newport News, Virginia, 23606, United States

Location

Vanda Investigational Site

Norfolk, Virginia, 23507, United States

Location

Vanda Investigational Site

Richmond, Virginia, 23233, United States

Location

Vanda Investigational Site

Spokane, Washington, 99202, United States

Location

Related Links

• Study Webpage

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Vanda Pharmaceuticals Inc.
• Organization: Vanda Pharmaceuticals Inc.

clinicaltrials@vandapharma.com

202-734-3400

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: June 26, 2018
• Study Start: July 9, 2018
• Primary Completion: December 27, 2019
• Study Completion: December 27, 2019
• Last Updated: May 13, 2024
• Results First Posted: May 13, 2024

Record last verified: 2024-04

Locations

US (70)