A Phase 2 Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy of Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Akron Children's Hospital
Summary
The goal of this study is to test the efficacy of Dupixent in improving post-burn itching symptoms versus the current standard of care.
Description
Participants will receive six injections of Dupixent or placebo (two 300 mg loading doses and one 300 mg dose every two weeks after that). In addition, participants will be asked to complete questionnaires to determine daily itch severity, quality of life, treatment benefit, physical functioning, and pain interference. Individual participants will require 13 weeks to complete all study visits.
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: • Persons 18-60 year old with post-burn hypertrophic scars of any size which required grafting or epidermal autografting for an acute burn injury, with continued complaint of pruritus due to inadequate relief from standard of care (medical management by antihistamine and neuroleptic medications) after at least four weeks and are a minimum of four weeks after their last grafting surgery, and who speak English sufficient to participate in the study. Exclusion Criteria: * Currently taking Dupixent for any other diagnosis * known allergy to Dupixent * pregnant and or lactati…
Interventions
- DrugDupilumab
injection every two weeks while on study
- OtherPlacebo
injection every two weeks while on study
Location
- Akron Children's HospitalAkron, Ohio