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
2 other identifiers
interventional
69
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2013
Shorter than P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2013
CompletedFirst Posted
Study publicly available on registry
December 6, 2013
CompletedStudy Start
First participant enrolled
December 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2015
CompletedResults Posted
Study results publicly available
June 11, 2024
CompletedJune 11, 2024
May 1, 2024
1.2 years
November 21, 2013
April 1, 2024
May 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
VLY-686
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Vanda Investigational Site
Düsseldorf, 40225, Germany
Vanda Investigational Site
Hamburg, 22083, Germany
Vanda Investigational Site
Jena, 07740, Germany
Vanda Investigational Site
Kiel, 24105, Germany
Vanda Investigational Site
Münster, 48147, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vanda Pharmaceuticals Inc.
- Organization
- Vanda Pharmaceuticals Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2013
First Posted
December 6, 2013
Study Start
December 10, 2013
Primary Completion
February 19, 2015
Study Completion
February 19, 2015
Last Updated
June 11, 2024
Results First Posted
June 11, 2024
Record last verified: 2024-05