RecruitingPhase 1Phase 2NCT06834035

Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa

Sponsor

M. Peter Marinkovich

Enrollment

8 participants

Start Date

Aug 4, 2025

Study Type

INTERVENTIONAL

Conditions

Epidermolysis Bullosa Dystrophic Epidermolysis Bullosa Epidermolysis Bullosa Acquisita

Summary

The study objective is to see if IV IgG treatment in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin in conjunction with VYJUVEK treatment improves wound healing and affects the levels of C7 and HSV-1 antibody levels in serum. Fewer wounds, more rapidly healing wounds, and decreased C7 and HSV-1 antibodies could improve quality of life.

Eligibility

Min Age: 6 Years

Inclusion Criteria6

Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations.
Diagnosis of EBA demonstrated by the presence of levels of serum C7 antibodies above the normal ELISA range
Baseline skin blistering greater than 5% total body surface area
wound at least 20 cm\^2 able to be entirely treated with Vyjuvek weekly
wound at least 20 cm\^2 that has never been treated with Vyjuvek
Ongoing VYJUVEK treatment.