Phase 2
N=69
Proof of Concept of VLY-686 in Subjects With Treatment-Resistant Pruritus Associated With Atopic Dermatitis
Treatment-resistant Pruritus Associated With Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT02004041 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Change From Baseline to Endpoint (Day 28 or Early Termination) in Visual Analogue Scale (VAS) Pruritus 24 Hour Average Intensity. — -40.5; -36.5 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VLY-686 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanda Pharmaceuticals
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Endpoint (Day 28 or Early Termination) in Visual Analogue Scale (VAS) Pruritus 24 Hour Average Intensity. |
-40.5; -36.5 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02004041). 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.