Treatment-resistant Pruritus Associated With Atopic Dermatitis
Conditions
Keywords
pruritus, atopic dermatitis, VLY-686
Brief summary
This is randomized, double-blind, placebo-controlled study to test whether VLY-686 can reduce chronic pruritus in subjects with treatment-resistant pruritus associated with atopic dermatitis in comparison with placebo.
Interventions
DRUGVLY-686
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
* Men and women ages 18 - 65 years, inclusive; suffering from atopic dermatitis with a SCORAD index at inclusion ≤80; with atopic lesions on arms, legs, trunk and neck; * Chronic pruritus with pruritus being actively present for at least 6 weeks prior to screening; * Males, non-fecund females, or females of child-bearing potential using 2 independent highly effective barrier methods of birth control when used correctly for a period of 35 days before the first dosing, during the study and for one month after the last dose and must have a negative pregnancy test at the screening and baseline visits.
Exclusion criteria
* Chronic pruritus due to conditions other than atopic dermatitis (AD) including the following conditions: Prurigo nodularis, Lichen simplex chronicus, Bullous pemphigoid; * Acute superinfection of AD.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Endpoint (Day 28 or Early Termination) in Visual Analogue Scale (VAS) Pruritus 24 Hour Average Intensity. | 28 days | Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left end point was marked no itch (0 mm) and in the right end point was marked worst imaginable itch (100 mm). |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VLY-686 VLY-686 | 34 |
| Placebo Placebo | 35 |
| Total | 69 |
Baseline characteristics
| Characteristic | VLY-686 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 36.6 years STANDARD_DEVIATION 15.6 | 40.2 years STANDARD_DEVIATION 14.5 | 38.4 years STANDARD_DEVIATION 15.1 |
| Pruritus 24 hours average intensity Visual Analogue Scale (VAS) at baseline | 76.1 units on a scale STANDARD_DEVIATION 9.74 | 77.2 units on a scale STANDARD_DEVIATION 10.87 | 76.6 units on a scale STANDARD_DEVIATION 10.27 |
| Region of Enrollment Germany | 34 participants | 35 participants | 69 participants |
| Sex: Female, Male Female | 19 Participants | 21 Participants | 40 Participants |
| Sex: Female, Male Male | 15 Participants | 14 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 34 |
| other Total, other adverse events | 12 / 34 | 11 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
Primary
Change From Baseline to Endpoint (Day 28 or Early Termination) in Visual Analogue Scale (VAS) Pruritus 24 Hour Average Intensity.
Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left end point was marked no itch (0 mm) and in the right end point was marked worst imaginable itch (100 mm).
Time frame: 28 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| VLY-686 | Change From Baseline to Endpoint (Day 28 or Early Termination) in Visual Analogue Scale (VAS) Pruritus 24 Hour Average Intensity. | -40.5 mm | Standard Error 5.3 |
| Placebo | Change From Baseline to Endpoint (Day 28 or Early Termination) in Visual Analogue Scale (VAS) Pruritus 24 Hour Average Intensity. | -36.5 mm | Standard Error 4.96 |