Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa
Key facts
- Who runs it
- M. Peter Marinkovich
- Where
- Redwood City, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 8 people, planned
- Started
- 4 Aug 2025
- Expected to end
- Mar 2027
- Type of study
- Interventional
- Treatments tested
- Immunoglobulin G
- Record updated
- 5 May 2026
Who can take part
- Age
- 6 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- History of thrombotic event(s)
- History of cardiac failure
- History of renal failure
- IgA deficiency
Where in United States
- Stanford UniversityRedwood City, United StatesContact: Clinical Research CoordinatorTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
Fewer wounds, more rapidly healing wounds, and decreased C7 and HSV-1 antibodies could improve quality of life.
The group in the trial
- Intra-Personal ControlTreatment being tested
There is one arm of the study. First, each participant undergoes a 3-month observational period, during which they continue application of their prescribed Vyjuvek. After 3 months, they enter the treatment period, during which they continue their Vyjuvek application and, in addition, receive the IV IgG treatment.
Treatment: Immunoglobulin G
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 5 May 2026