Phase 2 Completed N=69 Randomized Quadruple-blind Treatment

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

Treatment-resistant Pruritus Associated With Atopic Dermatitis

Source: ClinicalTrials.gov NCT02004041 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2024

Primary outcomePrimary: Change From Baseline to Endpoint (Day 28 or Early Termination) in Visual Analogue Scale (VAS) Pruritus 24 Hour Average Intensity. — -40.5; -36.5 mm

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Endpoint (Day 28 or Early Termination) in Visual Analogue Scale (VAS) Pruritus 24 Hour Average Intensity.	-40.5; -36.5	—

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02004041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.