Treatment-resistant Pruritus Associated With Atopic Dermatitis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Proof of Concept, Antipruritic Study of the Neurokinin-1 Receptor Antagonist VLY-686 in Subjects With Treatment-Resistant Pruritus Associated With Atopic Dermatitis
Verified date | May 2024 |
Source | Vanda Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 69 |
Est. completion date | February 19, 2015 |
Est. primary completion date | February 19, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Germany | Vanda Investigational Site | Dusseldorf | |
Germany | Vanda Investigational Site | Hamburg | |
Germany | Vanda Investigational Site | Jena | |
Germany | Vanda Investigational Site | Kiel | |
Germany | Vanda Investigational Site | Munster |
Lead Sponsor | Collaborator |
---|---|
Vanda Pharmaceuticals |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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). | 28 days |