Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis

Vyne Therapeutics Inc.484 enrolled

Overview

This is a double-blind, randomized, placebo-controlled study. Approximately 450 subjects will be randomized in a 1:1:1 ratio to receive daily oral doses of serlopitant 1 mg, 5 mg, or placebo for 6 weeks. During the screening period, subjects will be provided with an electronic device for recording electronic diary (eDiary) assessments throughout the study. This eDiary will be used to capture efficacy endpoint data and treatment information. At the Baseline visit, eligible subjects will be randomized, and study drug dispensed beginning with a loading dose of 3 tablets to be taken at bedtime that same day. Starting on Study Day 2, subjects will take one tablet per day at bedtime. Treatment will continue for 6 weeks. The primary efficacy endpoint will be assessed during Week 6. After completion of the 6-week treatment period, all subjects will enter a 4-week follow-up period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

484

Conditions

Pruritus Atopic Dermatitis

Interventions

Serlopitant High DoseDRUG

serlopitant tablets - high dose

Placebo Oral TabletDRUG

placebo tablet

Serlopitant Low DoseDRUG

serlopitant tablets - low dose

Eligibility

Sex: ALLMin age: 13 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female, age 13 years or older * Pruritus prior to and during the initial screening period * Diagnosis of atopic dermatitis * Judged to be in good health in the investigator's opinion Exclusion Criteria: * Prior treatment with study drug or similar drug * Pruritus due to another reason besides atopic dermatitis * Presence of any medical condition or disability that could interfere with study * History of hypersensitivity to serlopitant or any of its components * Currently pregnant or male partner of pregnant female * Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding

Locations (52)

Outcomes

Primary Outcomes

Change in WI-NRS From Baseline to Week 6

Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The primary outcome is the change in WI-NRS score between the visit and Baseline.

Time frame: Week 6 compared to Baseline

Secondary Outcomes

WI-NRS 4-point Responder Rate at Week 6

Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Week 6 and baseline.

Time frame: Week 6 compared to Baseline

Change in Quality of Life (ItchyQoL) From Baseline to Week 6

ItchyQoL is a 22-item pruritus-specific instrument that measures the degree to which pruritus affects quality-of-life. The responses to the items are Never (1), Rarely (2), Sometimes (3), Often (4) and All the Time (5). A higher score corresponds to a more adverse impact. The overall score is the average of the 22 items ranging from 1 to 5.

Time frame: Week 6 compared to Baseline

Data from ClinicalTrials.gov

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Study Site 332

Anniston, Alabama, United States

Study Site 363

Birmingham, Alabama, United States

Study Site 340

Hoover, Alabama, United States

Study Site 364

Glendale, Arizona, United States

Study Site 334

Cerritos, California, United States

Study Site 386

Encinitas, California, United States

Study Site 366

Fountain Valley, California, United States

Study Site 338

Los Angeles, California, United States

Study Site 383

North Hollywood, California, United States

Study Site 374

Oceanside, California, United States

...and 42 more locations