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

Phase 2

Terminated

• Conditions: Pruritus; Burns
• Interventions: Drug: Placebo; Drug: Serlopitant

• Registration Number: NCT02975271
• Lead Sponsor: Vyne Therapeutics Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-23
• Study First Posted: 2016-11-29
• Primary Completion: 2017-01-17
• Study Completion: 2017-01-17
• Disposition First Submitted: 2020-08-14
• Disposition First Submitted QC: 2020-08-20
• Disposition First Posted: 2020-08-26
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching dose of Placebo
Serlopitant	Serlopitant	Dose of experimental drug Serlopitant

Primary Outcome Measures

Name	Time	Method
Change in Itch Intensity - Numeric Rating Scale	Week 6

Secondary Outcome Measures

Name	Time	Method
Itch Intensity Responder Rate - Numeric Rating Scale	Week 6

Trial Locations

Locations (7)

Study Site 409; 🇺🇸 Lincoln, Nebraska, United States

Study Site 403; 🇺🇸 Tampa, Florida, United States

Study Site 413; 🇺🇸 Seattle, Washington, United States

Study Site 404; 🇺🇸 Phoenix, Arizona, United States

Study Site 412; 🇺🇸 Gainesville, Florida, United States

Study Site 402; 🇺🇸 Washington, District of Columbia, United States

Study Site 401; 🇺🇸 Winston-Salem, North Carolina, United States