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

May 18, 2021 updated by: Vyne Therapeutics Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

484

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States
        • Study Site 332
      • Birmingham, Alabama, United States
        • Study Site 363
      • Hoover, Alabama, United States
        • Study Site 340
    • Arizona
      • Glendale, Arizona, United States
        • Study Site 364
    • California
      • Cerritos, California, United States
        • Study Site 334
      • Encinitas, California, United States
        • Study Site 386
      • Fountain Valley, California, United States
        • Study Site 366
      • Los Angeles, California, United States
        • Study Site 338
      • North Hollywood, California, United States
        • Study Site 383
      • Oceanside, California, United States
        • Study Site 374
      • San Diego, California, United States
        • Study Site 347
      • San Diego, California, United States
        • Study Site 356
      • San Francisco, California, United States
        • Study Site 333
      • Santa Monica, California, United States
        • Study Site 376
    • Colorado
      • Denver, Colorado, United States
        • Study Site 358
    • Florida
      • Jacksonville, Florida, United States
        • Study Site 370
      • Miami, Florida, United States
        • Study Site 331
      • Miami, Florida, United States
        • Study Site 348
      • Miami, Florida, United States
        • Study Site 378
      • Pinellas Park, Florida, United States
        • Study Site 353
      • Tampa, Florida, United States
        • Study Site 368
      • Tampa, Florida, United States
        • Study Site 377
    • Georgia
      • Atlanta, Georgia, United States
        • Study Site 369
      • Savannah, Georgia, United States
        • Study Site 349
    • Illinois
      • Chicago, Illinois, United States
        • Study Site 381
    • Indiana
      • New Albany, Indiana, United States
        • Study Site 360
    • Kentucky
      • Bardstown, Kentucky, United States
        • Study Site 380
      • Louisville, Kentucky, United States
        • Study Site 344
    • Massachusetts
      • Boston, Massachusetts, United States
        • Study Site 379
    • Michigan
      • Warren, Michigan, United States
        • Study Site 350
    • Missouri
      • Saint Joseph, Missouri, United States
        • Study Site 371
    • Nevada
      • Las Vegas, Nevada, United States
        • Study Site 387
    • New Jersey
      • Berlin, New Jersey, United States
        • Study Site 352
    • New York
      • Forest Hills, New York, United States
        • Study Site 375
      • Rochester, New York, United States
        • Study Site 373
    • North Carolina
      • High Point, North Carolina, United States
        • Study Site 341
      • Shelby, North Carolina, United States
        • Study Site 355
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Study Site 337
    • Rhode Island
      • Johnston, Rhode Island, United States
        • Study Site 345
      • Providence, Rhode Island, United States
        • Study Site 362
    • South Carolina
      • Anderson, South Carolina, United States
        • Study Site 382
      • Spartanburg, South Carolina, United States
        • Study Site 343
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Study Site 357
    • Texas
      • Austin, Texas, United States
        • Study Site 365
      • Houston, Texas, United States
        • Study Site 335
      • Pflugerville, Texas, United States
        • Study Site 359
      • Plano, Texas, United States
        • Study Site 339
      • San Antonio, Texas, United States
        • Study Site 361
    • Utah
      • Draper, Utah, United States
        • Study Site 351
    • Virginia
      • Norfolk, Virginia, United States
        • Study Site 342
      • Richmond, Virginia, United States
        • Study Site 336
      • Richmond, Virginia, United States
        • Study Site 367

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Serlopitant High Dose
serlopitant tablets - high dose
Drug: Serlopitant High Dose
serlopitant tablets - high dose
Experimental: Serlopitant Low Dose
serlopitant tablets - low dose
Drug: Serlopitant Low Dose
serlopitant tablets - low dose
Placebo Comparator: Placebo Oral Tablet
matching placebo tablets
Drug: Placebo Oral Tablet
placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 6 compared to Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 6 compared to Baseline
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.
Week 6 compared to Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vyne Therapeutics Inc.

Investigators

  • Study Director: Mary Spellman, MD, Vyne Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

January 16, 2018

Study Completion (Actual)

February 23, 2018

Study Registration Dates

First Submitted

November 22, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (Estimate)

November 29, 2016

Study Record Updates

Last Update Posted (Actual)

May 20, 2021

Last Update Submitted That Met QC Criteria

May 18, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTI-103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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