Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury (AUBURN)

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 Following Burn Injury

Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

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
    • Arizona
      • Phoenix, Arizona, United States
        • Study Site 404
    • District of Columbia
      • Washington, District of Columbia, United States
        • Study Site 402
    • Florida
      • Gainesville, Florida, United States
        • Study Site 412
      • Tampa, Florida, United States
        • Study Site 403
    • Nebraska
      • Lincoln, Nebraska, United States
        • Study Site 409
    • North Carolina
      • Winston-Salem, North Carolina, United States
        • Study Site 401
    • Washington
      • Seattle, Washington, United States
        • Study Site 413

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Male or female, age 18-65 years at consent.
  • History of serious burn injury
  • Pruritus (itchiness) prior to the initial screening visit and during the screening period
  • Judged to be in good health in the investigator's opinion.

Key Exclusion Criteria:

  • Prior treatment with study drug or similar drug
  • Pruritus (itchiness) due to another reason besides burn injury/ healing.
  • Presence of any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.
  • History of hypersensitivity to study drug 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
Dose of experimental drug Serlopitant
Drug: Serlopitant
Placebo Comparator: Placebo
Matching dose of Placebo
Drug: Placebo
Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Itch Intensity - Numeric Rating Scale
Time Frame: Week 6
Week 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Itch Intensity Responder Rate - Numeric Rating Scale
Time Frame: Week 6
Week 6

Collaborators and Investigators

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

Sponsor

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 17, 2017

Study Completion (Actual)

January 17, 2017

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-104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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