Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa
Recruiting
Phase 1
Phase 2
Interventional Study
Epidermolysis Bullosa
Epidermolysis Bullosa Acquisita
Dystrophic Epidermolysis Bullosa
Recessive Dystrophic Epidermolysis Bullosa
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 8 (estimated)
- Sponsor
- M. Peter Marinkovich · Other
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About This Trial
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.
Trial Locations
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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 s…
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