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

Primary Purpose

Pruritus, Burns

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Serlopitant
Placebo
Sponsored by
Vyne Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pruritus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Study Site 404
  • Study Site 402
  • Study Site 412
  • Study Site 403
  • Study Site 409
  • Study Site 401
  • Study Site 413

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Serlopitant

Placebo

Arm Description

Dose of experimental drug Serlopitant

Matching dose of Placebo

Outcomes

Primary Outcome Measures

Change in Itch Intensity - Numeric Rating Scale

Secondary Outcome Measures

Itch Intensity Responder Rate - Numeric Rating Scale

Full Information

First Posted
November 22, 2016
Last Updated
May 18, 2021
Sponsor
Vyne Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02975271
Brief Title
Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury
Acronym
AUBURN
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus Following Burn Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Business Reasons
Study Start Date
November 2016 (Actual)
Primary Completion Date
January 17, 2017 (Actual)
Study Completion Date
January 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vyne Therapeutics Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus, Burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Serlopitant
Arm Type
Experimental
Arm Description
Dose of experimental drug Serlopitant
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching dose of Placebo
Intervention Type
Drug
Intervention Name(s)
Serlopitant
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Change in Itch Intensity - Numeric Rating Scale
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Itch Intensity Responder Rate - Numeric Rating Scale
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Study Site 404
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Study Site 402
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Study Site 412
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Study Site 403
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Study Site 409
City
Lincoln
State/Province
Nebraska
Country
United States
Facility Name
Study Site 401
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Study Site 413
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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