Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa
NCT ID: NCT06834035
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
8 participants
INTERVENTIONAL
2025-08-04
2026-03-06
Brief Summary
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Fewer wounds, more rapidly healing wounds, and decreased C7 and HSV-1 antibodies could improve quality of life.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intra-Personal Control
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.
Immunoglobulin G
Purified IgG from human serum, delivered via IV
Interventions
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Immunoglobulin G
Purified IgG from human serum, delivered via IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 surface area
4. 1 wound at least 20 cm\^2 able to be entirely treated with Vyjuvek weekly
5. 1 wound at least 20 cm\^2 that has never been treated with Vyjuvek
6. Ongoing VYJUVEK treatment.
Exclusion Criteria
2. History of cardiac failure
3. History of renal failure
4. IgA deficiency
6 Years
ALL
No
Sponsors
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Epidermolysis Bullosa Research Partnership
OTHER_GOV
M. Peter Marinkovich
OTHER
Responsible Party
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M. Peter Marinkovich
Associate Professor of Dermatology
Principal Investigators
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Matt P Marinkovich, MD
Role: PRINCIPAL_INVESTIGATOR
Associate Professor of Dermatology
Locations
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Stanford University
Redwood City, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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73958
Identifier Type: -
Identifier Source: org_study_id
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