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Completed

NCT Number: NCT02975206

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

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

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Key information

Conditions

Pruritus Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin Manifestations Skin and Connective Tissue Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Study Site 332, Anniston, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serlopitant High Dose

Drug

serlopitant tablets - high dose

Placebo oral tablet

Drug

placebo tablet

Serlopitant Low Dose

Drug

serlopitant tablets - low dose

Primary outcomes

  1. Change in WI-NRS From Baseline to Week 6

    Time frame: Week 6 compared to Baseline

    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.

Secondary outcomes

  1. WI-NRS 4-point Responder Rate at Week 6

    Time frame: Week 6 compared to Baseline

    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.

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

    Time frame: Week 6 compared to Baseline

    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.

Sponsors and collaborators

Lead sponsor

Vyne Therapeutics Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo Controlled Study Of The Efficacy, Safety, And Tolerability Of Serlopitant For The Treatment Of Pruritus In Adults And Adolescents With A History Of Atopic Dermatitis

Acronym: ATOMIK

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 29, 2016
Registry last updated
May 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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