Overview

Dupilumab in the Treatment of Keloids

Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
This study is a prospective, randomized, double blind, placebo-controlled clinical trial. The study will include a total of 44 subjects with clinically measurable keloid lesions. At least 50% of subjects (at least 22 out of the 44 subjects) will also have documented diagnosis of concomitant type 2 atopic/allergic) inflammatory diseases. In Phase I, subjects will be randomized (3:1) to either receive weekly dupilumab or placebo for 24 weeks. At Week 24, both groups will enter Phase II of the study in which all subjects will receive weekly doses of dupilumab up to Week 52. The treatment period will conclude at Week 52.
Phase:
Phase 4
Details
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborators:
Regeneron Pharmaceuticals
Sanofi