Recruiting NCT06834035
Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immunoglobulin G.
- Who it may be relevant to
- Registry conditions: Epidermolysis Bullosa, Epidermolysis Bullosa Acquisita, Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa. Basic parameters: from 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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]
- Percent Change in Wound Area [Time frame: 9 Months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stanford University — Redwood City
Identifiers
NCT: NCT06834035 · 73958