Study of IV Immunoglobulin G with Vyjuvek to Improve Wound Healing in Recessive Dystrophic Epidermolysis Bullosa

What this Trial Is About

Researchers are studying whether intravenous Immunoglobulin G IV IgG treatment combined with Vyjuvek application can improve wound healing and affect certain antibody levels in people with Recessive Dystrophic Epidermolysis Bullosa RDEB. This study aims to see if fewer wounds, faster healing, and decreased levels of Collagen VII and HSV-1 antibodies can improve quality of life for participants. The trial is led by M. Peter Marinkovich and is a Phase 12 interventional study. The study has one main arm where participants first undergo a 3-month observation period while continuing their prescribed Vyjuvek treatment. After this period, they enter the treatment phase, continuing Vyjuvek and adding IV IgG infusions. This biological treatment is purified IgG from human serum given intravenously. The combination aims to evaluate changes in wound healing and antibody levels over the study duration. Participants will be monitored for adverse events and changes in wound size over 9 months. Researchers will assess wound healing progress, antibody levels in the serum, and overall safety of the combined treatments. The study involves regular wound evaluation and ongoing Vyjuvek application, with assessments focused on wound area and immune response markers to understand the treatment effects.

Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa