Burns, Pruritus
Conditions
Brief summary
Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury
Interventions
DRUGSerlopitant
DRUGPlacebo
Matching placebo
Sponsors
Vyne Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Itch Intensity - Numeric Rating Scale | Week 6 |
Secondary
| Measure | Time frame |
|---|---|
| Itch Intensity Responder Rate - Numeric Rating Scale | Week 6 |
Countries
United States
Outcome results
None listed