Study Stopped
Business Decision
Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE2)
A Randomized, Double-blind, Placebo-controlled, Efficacy Study of the Neurokinin-1 Receptor Antagonist VLY-686 in Patients With Atopic Dermatitis
2 other identifiers
interventional
87
1 country
51
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2019
Shorter than P25 for phase_3
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 21, 2019
CompletedFirst Submitted
Initial submission to the registry
October 24, 2019
CompletedFirst Posted
Study publicly available on registry
October 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 14, 2020
CompletedResults Posted
Study results publicly available
May 14, 2024
CompletedMay 14, 2024
April 1, 2024
12 months
October 24, 2019
April 1, 2024
April 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2
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
Study Arms (2)
Tradipitant
EXPERIMENTALOral Capsule
Placebo
PLACEBO COMPARATOROral Capsule
Interventions
Eligibility Criteria
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 60 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Vanda Investigational Site
Hoover, Alabama, 35244, United States
Vanda Investigational Site
Tempe, Arizona, 85281, United States
Vanda Investigational Site
Encino, California, 91436, United States
Vanda Investigational Site
Fountain Valley, California, 92708, United States
Vanda Investigational Site
Laguna Hills, California, 92653, United States
Vanda Investigational Site
Lomita, California, 90717, United States
Vanda Investigational Site
Los Angeles, California, 90025, United States
Vanda Investigational Site
Los Angeles, California, 90036, United States
Vanda Investigational Site
Los Angeles, California, 90057, United States
Vanda Investigational Site
Denver, Colorado, 80220, United States
Vanda Investigational Site
Clearwater, Florida, 33756, United States
Vanda Investigational Site
Miami, Florida, 33126, United States
Vanda Investigational Site
Tampa, Florida, 33613, United States
Vanda Investigational Site
Savannah, Georgia, 31406, United States
Vanda Investigational Site
Boise, Idaho, 83704, United States
Vanda Investigational Site
Chicago, Illinois, 60611, United States
Vanda Investigational Site
Normal, Illinois, 61761, United States
Vanda Investigational Site
Skokie, Illinois, 60077, United States
Vanda Investigational Site
Plainfield, Indiana, 46168, United States
Vanda Investigational Site
Crowley, Louisiana, 70526, United States
Vanda Investigational Site
Timonium, Maryland, 21093, United States
Vanda Investigational Site
Fort Gratiot, Michigan, 48059, United States
Vanda Investigational Site
Saint Joseph, Missouri, 64506, United States
Vanda Investigational Site
St Louis, Missouri, 63141, United States
Vanda Investigational Site
Omaha, Nebraska, 68144, United States
Vanda Investigational Site
Las Vegas, Nevada, 89119, United States
Vanda Investigational Site
Berlin, New Jersey, 08009, United States
Vanda Investigational Site
Hoboken, New Jersey, 07030, United States
Vanda Investigational Site
Verona, New Jersey, 07044, United States
Vanda Investigational Site
Kew Gardens, New York, 11415, United States
Vanda Investigational Site
New York, New York, 10022, United States
Vanda Investigational Site
New York, New York, 10075, United States
Vanda Investigational Site
The Bronx, New York, 10458, United States
Vanda Investigational Site
Charlotte, North Carolina, 28277, United States
Vanda Investigational Site
Cincinnati, Ohio, 45212, United States
Vanda Investigational Site
Oklahoma City, Oklahoma, 73112, United States
Vanda Investigational Site
Tulsa, Oklahoma, 74136, United States
Vanda Investigational Site
Philadelphia, Pennsylvania, 19103, United States
Vanda Investigational Site
Johnston, Rhode Island, 02919, United States
Vanda Investigational Site
Spartanburg, South Carolina, 29301, United States
Vanda Investigational Site
Spartanburg, South Carolina, 29303, United States
Vanda Investigational Site
Dallas, Texas, 75230, United States
Vanda Investigational Site
Houston, Texas, 77004, United States
Vanda Investigational Site
Houston, Texas, 77065, United States
Vanda Investigational Site
Mesquite, Texas, 75149, United States
Vanda Investigational Site
South Jordan, Utah, 84095, United States
Vanda Investigational Site
South Burlington, Vermont, 05403, United States
Vanda Investigational Site
Alexandria, Virginia, 22311, United States
Vanda Investigational Site
Newport News, Virginia, 23606, United States
Vanda Investigational Site
Norfolk, Virginia, 23502, United States
Vanda Investigational Site
Spokane, Washington, 99202, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was discontinued early and therefore the study was not powered for appropriate examination of primary and secondary endpoints.
Results Point of Contact
- Title
- Vanda Pharmaceuticals Inc.
- Organization
- Vanda Pharmaceuticals Inc.
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
October 24, 2019
First Posted
October 28, 2019
Study Start
October 21, 2019
Primary Completion
October 14, 2020
Study Completion
October 14, 2020
Last Updated
May 14, 2024
Results First Posted
May 14, 2024
Record last verified: 2024-04