Phase 2
N=168
Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT02651714 ↗Enrolled (actual)
168
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score — -41.5; -35.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tradipitant (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanda Pharmaceuticals
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score |
-41.5; -35.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02651714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.