Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis
1 other identifier
interventional
168
1 country
28
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with treatment-resistant pruritus diagnosed with atopic dermatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2016
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2016
CompletedFirst Posted
Study publicly available on registry
January 11, 2016
CompletedStudy Start
First participant enrolled
January 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2017
CompletedResults Posted
Study results publicly available
June 13, 2024
CompletedJune 13, 2024
May 1, 2024
1.5 years
January 6, 2016
April 1, 2024
May 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score
Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left endpoint was marked "no itch" (0 mm) and in the right endpoint was marked "worst imaginable itch" (100 mm).
56 days
Study Arms (2)
Tradipitant
EXPERIMENTALOral
Placebo
PLACEBO COMPARATOROral
Interventions
Eligibility Criteria
You may qualify if:
- Male and non-pregnant, non-lactating female subjects aged 18 - 65 years (inclusive)
- Diagnosed with atopic dermatitis
- Suffering from chronic pruritus with pruritus being actively present
You may not qualify if:
- Chronic pruritus due to condition other than atopic dermatitis (AD)
- Participation in a previous tradipitant (LY686017 or VLY-686) trial
- Anyone affiliated with the site or sponsor and/or anyone who may consent under duress
- Any other sound medical reason as determined by the Investigator including any condition which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance or may confound study results
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Vanda Investigational Site
Encinitas, California, 92024, United States
Vanda Investigational Site
Encino, California, 91436, United States
Vanda Investigational Site
Lomita, California, 90717, United States
Vanda Investigational Site
San Diego, California, 92122, United States
Vanda Investigational Site
San Diego, California, 92123, United States
Vanda Investigational Site
Miami, Florida, 33126, United States
Vanda Investigational Site
Miami, Florida, 33136, United States
Vanda Investigational Site
Ormond Beach, Florida, 32174, United States
Vanda Investigational Site
Columbus, Georgia, 31904, United States
Vanda Investigational Site
Plainfield, Indiana, 46168, United States
Vanda Investigational Site
Crowley, Louisiana, 70526, United States
Vanda Investigational Site
St Louis, Missouri, 63110, United States
Vanda Investigational Site
Las Vegas, Nevada, 89119, 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
High Point, North Carolina, 27262, United States
Vanda Investigational Site
Wilmington, North Carolina, 28405, United States
Vanda Investigational Site
Winston-Salem, North Carolina, 27104, United States
Vanda Investigational Site
Portland, Oregon, 97239, United States
Vanda Investigational Site
Philadelphia, Pennsylvania, 19104, United States
Vanda Investigational Site
Johnston, Rhode Island, 02919, United States
Vanda Investigational Site
Charleston, South Carolina, 29407, United States
Vanda Investigational Site
Houston, Texas, 77030, United States
Vanda Investigational Site
Pflugerville, Texas, 78660, United States
Vanda Investigational Site
San Antonio, Texas, 78218, United States
Vanda Investigational Site
West Jordan, Utah, 84088, United States
Vanda Investigational Site
Seattle, Washington, 98101, United States
Vanda Investigational Site
Spokane, Washington, 99202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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 2
- 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
January 6, 2016
First Posted
January 11, 2016
Study Start
January 19, 2016
Primary Completion
August 4, 2017
Study Completion
August 4, 2017
Last Updated
June 13, 2024
Results First Posted
June 13, 2024
Record last verified: 2024-05