Atopic Dermatitis
Conditions
Keywords
eczema, chronic pruritus
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.
Interventions
DRUGTradipitant
DRUGPlacebo
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score | 56 days | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tradipitant Oral
Tradipitant | 84 |
| Placebo Oral
Placebo | 84 |
| Total | 168 |
Baseline characteristics
| Characteristic | Tradipitant | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 41.05 years STANDARD_DEVIATION 13.139 | 39.13 years STANDARD_DEVIATION 13.568 | 40.09 years STANDARD_DEVIATION 13.35 |
| Average Pruritus VAS at Baseline | 81.3 mm STANDARD_DEVIATION 10.78 | 80.3 mm STANDARD_DEVIATION 8.68 | 80.8 mm STANDARD_DEVIATION 9.77 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants | 21 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants | 63 Participants | 124 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 5 Participants | 11 Participants |
| Race/Ethnicity, Customized Black or African American | 24 Participants | 18 Participants | 42 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 49 Participants | 57 Participants | 106 Participants |
| Region of Enrollment United States | 84 Participants | 84 Participants | 168 Participants |
| Sex: Female, Male Female | 52 Participants | 53 Participants | 105 Participants |
| Sex: Female, Male Male | 32 Participants | 31 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 83 | 0 / 82 |
| other Total, other adverse events | 4 / 83 | 9 / 82 |
| serious Total, serious adverse events | 0 / 83 | 0 / 82 |
Outcome results
Primary
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).
Time frame: 56 days
Population: All participants randomized (1:1) to placebo or tradipitant.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tradipitant | Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score | -41.5 score on a scale | Standard Error 3.89 |
| Placebo | Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score | -35.8 score on a scale | Standard Error 4.03 |