A Phase 2 Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy of Dupixent in Adults With Refractory Post-Burn Pruritus

What this Trial Is About

This research aims to test how well Dupixent works to improve itching symptoms that happen after burns, compared to the current standard treatments. The study focuses on adults with post-burn hypertrophic scars who continue to experience itching despite standard care. It is a phase 2, randomized, placebo-controlled trial sponsored by Akron Children's Hospital. Participants will receive six injections of either Dupixent or a placebo over a 12-week period. The dosing starts with two 300 mg loading doses followed by one 300 mg dose every two weeks. Injections are given under the skin in areas such as the thigh, lower abdomen, or upper arm. No dose changes will be made during the study, and the first two doses will be given at separate injection sites. During the 13 weeks of participation, individuals will complete questionnaires that assess daily itch severity, quality of life, treatment benefit, physical functioning, and pain interference. Researchers will measure outcomes using the Itch Severity Scale after 12 weeks. The study includes close monitoring and visits to complete all assessments and injections within the set timeline.

Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic