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

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

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.

Study Overview

• Status: Completed
• Conditions: Treatment-resistant Pruritus Associated With Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: VLY-686

Detailed Description

This is randomized, double-blind, placebo-controlled study to be conducted at two sites in Germany. Sixty-eight (68) subjects with chronic pruritus associated with atopic dermatitis, will be randomized to either the placebo group or the active treatment group with VLY-686. The study is divided into three phases: the screening phase, the evaluation phase, and the post-therapy follow-up phase. The screening phase comprises a screening visit when subjects' preliminary eligibility for the study will be evaluated and a wash-out period when subjects will stop use of any current topical or systemic treatment. The evaluation period comprises 4 weeks of randomized double-blind treatment. The post-therapy follow-up period consists of a wash-out followed by a clinic visit for safety assessments and to check for residual efficacy of the treatment.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Dusseldorf, Germany, 40225
    • Vanda Investigational Site
  • Hamburg, Germany, 22083
    • Vanda Investigational Site
  • Jena, Germany, 07740
    • Vanda Investigational Site
  • Kiel, Germany, 24105
    • Vanda Investigational Site
  • Munster, Germany, 48147
    • Vanda Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: VLY-686	Drug: VLY-686

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Efficacy of VLY-686 on reducing atopic dermatitis skin lesions using SCORAD	4 weeks
Evaluate time course changes in VRS scores	4 weeks
Effect of VLY-686 on physiology of skin as measured by TransEpidermal Water Loss (TEWL)	4 weeks
Effect of VLY-686 on the subjective measure of Patient Benefit Index (PBI).	4 weeks
Measurement of nerve fiber density and NK-1 receptor density in exploratory skin biopsies.	4 weeks
Number of adverse events in subjects taking placebo	4 weeks
Explore the contribution of genetic factors on safety outcomes (e.g. number of adverse events, changes in vital signs, changes in laboratory values).	4 weeks
Evaluate time course changes in VAS scores	4 weeks
Explore the contribution of genetic factors on efficacy outcomes (e.g. VRS, VAS, SCORAD)	4 weeks
Number of adverse events in subjects taking VLY-686	4 weeks
Effect of VLY-686 on physiology of skin as measured by Skin Hydration.	4 weeks
Efficacy of VLY-686 on reducing atopic dermatitis skin lesions using Eczema Area and Severity Index (EASI)	4 weeks
Effect of VLY-686 on the subjective measure of Dermatology Life Quality Index (DLQI).	4 weeks
Effect of VLY-686 on the Clinical Global Impression-Change (CGI-C).	4 weeks

Collaborators and Investigators

• Sponsor: Vanda Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2013
• Primary Completion (Actual): February 19, 2015
• Study Completion (Actual): February 19, 2015

Study Registration Dates

• First Submitted: November 21, 2013
• First Submitted That Met QC Criteria: December 2, 2013
• First Posted (Estimated): December 6, 2013

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: atopic dermatitis; pruritus; VLY-686
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Manifestations; Skin Diseases, Eczematous; Dermatitis; Eczema; Pruritus; Dermatitis, Atopic
• Other Study ID Numbers: VP-VLY-686-2101; 2013-002931-25 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No