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

Phase 2

Completed

• Conditions: Treatment-resistant Pruritus Associated With Atopic Dermatitis
• Interventions: Drug: VLY-686; Drug: Placebo

• Registration Number: NCT02004041
• Lead Sponsor: Vanda Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-06
• Study Start: 2013-12-10
• Primary Completion: 2015-02-19
• Study Completion: 2015-02-19
• Results First Submitted: 2024-04-01
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-16
• Last Update Submitted: 2024-05-16
• Results First Posted: 2024-06-11
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VLY-686	VLY-686	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Vanda Investigational Site; 🇩🇪 Munster, Germany