Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa

NCT06834035 — Phase 1 / Phase 2, Recruiting, 8 participants, M. Peter Marinkovich

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Registry	NCT06834035, acronym IV IgG
Status	Recruiting
Phase	Phase 1 / Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	8 (Estimated)
Sponsor	M. Peter Marinkovich (Other); collaborators: Epidermolysis Bullosa Research Partnership
Conditions	Epidermolysis Bullosa, Epidermolysis Bullosa Acquisita, Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa
Interventions	Immunoglobulin G (Biological)
Dates	start 2025-08-04, primary completion 2027-03-01 (estimated), completion 2027-03-01 (estimated), first posted 2025-02-19, last updated 2026-05-05
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Intra-Personal Control	Experimental	Biological: Immunoglobulin G	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 (Biological), also known as IgG, IV IgG: Purified IgG from human serum, delivered via IV

+Outcome measures

Primary outcomes

Adverse Events and Effects [9 Months]: Occurrence of adverse events and effects
Percent Change in Wound Area [9 Months]: 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.

+Eligibility

Sex: All, ages: 6 Years to any

Inclusion Criteria:

1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations.
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:

1. History of thrombotic event(s)
2. History of cardiac failure
3. History of renal failure
4. IgA deficiency

+Locations (1)

Facility	City	Country	Status
Stanford University	Redwood City, California	United States	Recruiting

+Investigators

Matt P Marinkovich, MD, Principal investigator, Associate Professor of Dermatology