NCT06834035 · M. Peter Marinkovich
Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa
(IV IgG)
What this study is about
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.
View original scientific description
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.
Interventions
BIOLOGICAL
Immunoglobulin G
Purified IgG from human serum, delivered via IV
Primary outcome measures
Adverse Events and Effects
Time frame: 9 Months
Occurrence of adverse events and effects
Percent Change in Wound Area
Time frame: 9 Months
The wound area at the end of the treatment phase compared to the wound area at the beginning of the treatment phase. Wound healing (% and cm\^2) over the course of the treatment phase compared to the wound healing (% and cm\^2), over the observation phase.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 1 wound at least 20 cm\^2 able to be entirely treated with Vyjuvek weekly
- 1 wound at least 20 cm\^2 that has never been treated with Vyjuvek
- Ongoing VYJUVEK treatment.
Exclusion criteria
- History of thrombotic event(s)
- History of cardiac failure
- History of renal failure
- IgA deficiency
Where
- Redwood City, California
Collaborators
Epidermolysis Bullosa Research Partnership
Related conditions & keywords
Frequently asked questions
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Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations