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

• Sponsor: Vyne Therapeutics Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02975271
• Collaborator: (none)
• Enrollment: 1
• Locations: 7
• Arms: 2
• Actual Duration (Months): 2.5
• Patients Per Site: 0.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pruritus; Burns	Drug: Serlopitant; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Nov 1, 2016
• Actual Primary Completion Date: Jan 17, 2017
• Actual Study Completion Date: Jan 17, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Serlopitant Dose of experimental drug Serlopitant	Drug: Serlopitant
Placebo Comparator: Placebo Matching dose of Placebo	Drug: Placebo; Matching placebo

Outcome Measures

Primary Outcome Measures

1. Change in Itch Intensity - Numeric Rating Scale [Week 6]

Secondary Outcome Measures

1. Itch Intensity Responder Rate - Numeric Rating Scale [Week 6]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Study Site 404	Phoenix	Arizona	United States
2	Study Site 402	Washington	District of Columbia	United States
3	Study Site 412	Gainesville	Florida	United States
4	Study Site 403	Tampa	Florida	United States
5	Study Site 409	Lincoln	Nebraska	United States
6	Study Site 401	Winston-Salem	North Carolina	United States
7	Study Site 413	Seattle	Washington	United States

Sponsors and Collaborators

• Vyne Therapeutics Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vyne Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT02975271
• Other Study ID Numbers: MTI-104
• First Posted: Nov 29, 2016
• Last Update Posted: May 20, 2021
• Last Verified: May 1, 2021

• Additional relevant MeSH terms: Pruritus; Burns; Serlopitant

Study Results

No Results Posted as of May 20, 2021