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

• Status: Terminated
• Trial end date: 2017-01-17
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menlo Therapeutics Inc.; Vyne Therapeutics Inc.
• Treatments: Serlopitant

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.