- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04140695
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
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Alabama
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Hoover, Alabama, United States, 35244
- Vanda Investigational Site
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Arizona
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Tempe, Arizona, United States, 85281
- Vanda Investigational Site
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California
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Encino, California, United States, 91436
- Vanda Investigational Site
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Fountain Valley, California, United States, 92708
- Vanda Investigational Site
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Laguna Hills, California, United States, 92653
- Vanda Investigational Site
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Lomita, California, United States, 90717
- Vanda Investigational Site
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Los Angeles, California, United States, 90036
- Vanda Investigational Site
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Los Angeles, California, United States, 90025
- Vanda Investigational Site
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Los Angeles, California, United States, 90057
- Vanda Investigational Site
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Colorado
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Denver, Colorado, United States, 80220
- Vanda Investigational Site
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Florida
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Clearwater, Florida, United States, 33756
- Vanda Investigational Site
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Miami, Florida, United States, 33126
- Vanda Investigational Site
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Tampa, Florida, United States, 33613
- Vanda Investigational Site
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Georgia
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Savannah, Georgia, United States, 31406
- Vanda Investigational Site
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Idaho
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Boise, Idaho, United States, 83704
- Vanda Investigational Site
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Illinois
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Chicago, Illinois, United States, 60611
- Vanda Investigational Site
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Normal, Illinois, United States, 61761
- Vanda Investigational Site
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Skokie, Illinois, United States, 60077
- Vanda Investigational Site
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Indiana
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Plainfield, Indiana, United States, 46168
- Vanda Investigational Site
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Louisiana
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Crowley, Louisiana, United States, 70526
- Vanda Investigational Site
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Maryland
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Timonium, Maryland, United States, 21093
- Vanda Investigational Site
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Michigan
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Fort Gratiot, Michigan, United States, 48059
- Vanda Investigational Site
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Missouri
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Saint Joseph, Missouri, United States, 64506
- Vanda Investigational Site
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Saint Louis, Missouri, United States, 63141
- Vanda Investigational Site
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Nebraska
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Omaha, Nebraska, United States, 68144
- Vanda Investigational Site
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Nevada
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Las Vegas, Nevada, United States, 89119
- Vanda Investigational Site
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New Jersey
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Berlin, New Jersey, United States, 08009
- Vanda Investigational Site
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Hoboken, New Jersey, United States, 07030
- Vanda Investigational Site
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Verona, New Jersey, United States, 07044
- Vanda Investigational Site
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New York
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Bronx, New York, United States, 10458
- Vanda Investigational Site
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Kew Gardens, New York, United States, 11415
- Vanda Investigational Site
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New York, New York, United States, 10022
- Vanda Investigational Site
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New York, New York, United States, 10075
- Vanda Investigational Site
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North Carolina
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Charlotte, North Carolina, United States, 28277
- Vanda Investigational Site
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Ohio
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Cincinnati, Ohio, United States, 45212
- Vanda Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
- Vanda Investigational Site
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Tulsa, Oklahoma, United States, 74136
- Vanda Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19103
- Vanda Investigational Site
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Rhode Island
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Johnston, Rhode Island, United States, 02919
- Vanda Investigational Site
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South Carolina
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Spartanburg, South Carolina, United States, 29301
- Vanda Investigational Site
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Spartanburg, South Carolina, United States, 29303
- Vanda Investigational Site
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Texas
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Dallas, Texas, United States, 75230
- Vanda Investigational Site
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Houston, Texas, United States, 77004
- Vanda Investigational Site
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Houston, Texas, United States, 77065
- Vanda Investigational Site
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Mesquite, Texas, United States, 75149
- Vanda Investigational Site
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Utah
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South Jordan, Utah, United States, 84095
- Vanda Investigational Site
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Vermont
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South Burlington, Vermont, United States, 05403
- Vanda Investigational Site
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Virginia
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Alexandria, Virginia, United States, 22311
- Vanda Investigational Site
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Newport News, Virginia, United States, 23606
- Vanda Investigational Site
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Norfolk, Virginia, United States, 23502
- Vanda Investigational Site
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Washington
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Spokane, Washington, United States, 99202
- Vanda Investigational Site
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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
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 |
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Experimental: Tradipitant
Oral Capsule
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BID
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Placebo Comparator: Placebo
Oral Capsule
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BID
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2
Time Frame: 2 weeks
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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".
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2 weeks
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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
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8 weeks
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Improvement of disease severity in atopic dermatitis
Time Frame: 8 weeks
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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.
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8 weeks
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Improvement of disease severity in atopic dermatitis
Time Frame: 8 weeks
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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.
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8 weeks
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Improvement of disease severity in atopic dermatitis
Time Frame: 8 weeks
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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.
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8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
Clinical Trials on Atopic Dermatitis
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Catalysis SLCompletedAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related Conditions | Atopic Dermatitis \(AD\)Serbia
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Jacob Pontoppidan ThyssenThe Novo Nordic FoundationRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis FlareDenmark
-
Apollo Therapeutics LtdRecruitingDermatitis | Eczema | Atopic Dermatitis | Atopic | Eczema, Atopic | Dermatologic Disease | Eczema Atopic DermatitisUnited States, Canada
-
ShaperonRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis of ScalpUnited States
-
University of California, San FranciscoSanofi; Regeneron PharmaceuticalsCompletedEczema | Atopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related ConditionsUnited States
-
AmgenCompletedDermatitis, Atopic DermatitisCanada, United States, Japan
-
PfizerTerminatedEczema | Atopic Dermatitis | Eczema, Atopic | Atopic Dermatitis, UnspecifiedUnited States, Canada, Czechia, Poland
-
Hadassah Medical OrganizationUnknownATOPIC DERMATITIS
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Oregon Health and Science UniversityUniversity of Colorado, Denver; University of Wisconsin, Madison; Duke UniversityActive, not recruitingEczema | Atopic Dermatitis | Atopic Eczema | Atopic DisordersUnited States
-
Regeneron PharmaceuticalsSanofiCompletedHypersensitivity, Immediate | Dermatitis, Atopic | Moderate-to-Severe Atopic Dermatitis | Dermatitis, Dermatitis Atopic | Eczema, Skin Diseases, Skin | Diseases Genetic, Genetic | Diseases Inborn, Skin | Disease, Eczematous Skin | Hypersensitivity, Immune System DiseasesUnited States, Canada
Clinical Trials on Tradipitant
-
Vanda PharmaceuticalsRecruitingGastroparesis | Diabetic Gastroparesis | Idiopathic GastroparesisUnited States
-
Vanda PharmaceuticalsRecruitingMotion SicknessUnited States
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Vanda PharmaceuticalsCompletedAtopic DermatitisUnited States
-
Vanda PharmaceuticalsCompletedMotion SicknessUnited States
-
Vanda PharmaceuticalsCompletedMotion SicknessUnited States
-
Vanda PharmaceuticalsAvailableGastroparesis | Diabetic GastroparesisUnited States
-
Vanda PharmaceuticalsUnknownGastroparesisUnited States
-
Vanda PharmaceuticalsMayo ClinicCompletedHealthy VolunteerUnited States
-
Xiao Jing (Iris) WangMayo ClinicEnrolling by invitation
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Vanda PharmaceuticalsUnknownCoronavirus InfectionUnited States