Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa

Launched by M. PETER MARINKOVICH · Feb 13, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for a rare skin condition called Recessive Dystrophic Epidermolysis Bullosa (RDEB), which causes painful skin blisters. The researchers want to find out if giving a treatment called IV IgG along with another treatment called VYJUVEK can help wounds heal faster and reduce certain antibodies in the blood that might be causing problems. The goal is to help patients have fewer wounds and improve their overall quality of life.

To participate in this study, individuals must have a confirmed diagnosis of RDEB, meaning they have specific genetic changes that affect their skin. They also need to have significant blistering on their skin and at least one wound that can be treated weekly with VYJUVEK. However, people with a history of certain serious health issues, like blood clots or heart problems, won’t be eligible. This study is not yet recruiting participants, but it aims to provide valuable information on how this combined treatment could benefit those living with RDEB.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations.
• • 2. Diagnosis of EBA demonstrated by the presence of levels of serum C7 antibodies above the normal ELISA range
• • 3. Baseline skin blistering greater than 5% total body surface area
• • 4. 1 wound at least 20 cm\^2 able to be entirely treated with Vyjuvek weekly
• • 5. 1 wound at least 20 cm\^2 that has never been treated with Vyjuvek
• • 6. Ongoing VYJUVEK treatment.
• Exclusion Criteria:
• • 1. History of thrombotic event(s)
• • 2. History of cardiac failure
• • 3. History of renal failure
• • 4. IgA deficiency