Proof of Concept of VLY-686 in Subjects With Treatment-Resistant Pruritus Associated With Atopic Dermatitis

Vanda Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Treatment-resistant Pruritus Associated With Atopic Dermatitis

Treatments

Drug: Placebo

Drug: VLY-686

Study type

Interventional

Funder types

Industry

Identifiers

NCT02004041

VP-VLY-686-2101

2013-002931-25 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

69 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.