Actively Recruiting
Targeting Collagen VII Antibodies With IV IgG Treatment in Dystrophic Epidermolysis Bullosa
Led by M. Peter Marinkovich · Updated on 2026-05-05
8
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M. Peter Marinkovich
Lead Sponsor
E
Epidermolysis Bullosa Research Partnership
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether intravenous Immunoglobulin G (IV IgG) treatment combined with Vyjuvek application can improve wound healing and affect certain antibody levels in people with Recessive Dystrophic Epidermolysis Bullosa (RDEB). This study aims to see if fewer wounds, faster healing, and decreased levels of Collagen VII and HSV-1 antibodies can improve quality of life for participants. The trial is led by M. Peter Marinkovich and is a Phase 1/2 interventional study. The study has one main arm where participants first undergo a 3-month observation period while continuing their prescribed Vyjuvek treatment. After this period, they enter the treatment phase, continuing Vyjuvek and adding IV IgG infusions. This biological treatment is purified IgG from human serum given intravenously. The combination aims to evaluate changes in wound healing and antibody levels over the study duration. Participants will be monitored for adverse events and changes in wound size over 9 months. Researchers will assess wound healing progress, antibody levels in the serum, and overall safety of the combined treatments. The study involves regular wound evaluation and ongoing Vyjuvek application, with assessments focused on wound area and immune response markers to understand the treatment effects.
CONDITIONS
Brief Title
Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) confirmed by COL7A1 mutations
- Diagnosis of Epidermolysis Bullosa Acquisita (EBA) with elevated serum C7 antibody levels
- Skin blistering covering more than 5% of total body surface area
- At least one wound of 20 cm^2 treatable weekly with Vyjuvek
- At least one wound of 20 cm^2 that has never been treated with Vyjuvek
- Ongoing treatment with Vyjuvek
You will not qualify if you...
- History of thrombotic events
- History of heart failure
- History of kidney failure
- IgA deficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 months
Participants continue their prescribed Vyjuvek application while being observed without additional intervention.
Duration - 6 months
Participants continue Vyjuvek application and receive intravenous Immunoglobulin G (IV IgG) treatment.
Trial Site Locations
Total: 1 location
1
Stanford University
Redwood City, California, United States, 94163
Actively Recruiting
Research Team
K
Kunju Clinical Research Coordinator, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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