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

Vyne Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Burns; Pruritus

Treatments: Drug: Serlopitant; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02975271

MTI-104

Details and patient eligibility

About

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

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1 participants in 2 patient groups, including a placebo group

Serlopitant

Experimental group

Description:

Dose of experimental drug Serlopitant

Treatment:

Drug: Serlopitant

Placebo

Placebo Comparator group

Description:

Matching dose of Placebo

Treatment:

Drug: Placebo