Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa
IV IgG
1 other identifier
interventional
8
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2025
CompletedFirst Posted
Study publicly available on registry
February 19, 2025
CompletedStudy Start
First participant enrolled
August 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
May 5, 2026
April 1, 2026
1.6 years
February 13, 2025
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adverse Events and Effects
Occurrence of adverse events and effects
9 Months
Percent Change in Wound Area
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.
9 Months
Study Arms (1)
Intra-Personal Control
EXPERIMENTALThere 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.
Interventions
Purified IgG from human serum, delivered via IV
Eligibility Criteria
You may qualify if:
- 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
- wound at least 20 cm\^2 able to be entirely treated with Vyjuvek weekly
- wound at least 20 cm\^2 that has never been treated with Vyjuvek
- Ongoing VYJUVEK treatment.
You may not qualify if:
- History of thrombotic event(s)
- History of cardiac failure
- History of renal failure
- IgA deficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Epidermolysis Bullosa Research Partnershipcollaborator
- M. Peter Marinkovichlead
Study Sites (1)
Stanford University
Redwood City, California, 94163, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matt P Marinkovich, MD
Associate Professor of Dermatology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Dermatology
Study Record Dates
First Submitted
February 13, 2025
First Posted
February 19, 2025
Study Start
August 4, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
May 5, 2026
Record last verified: 2026-04