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RecruitingNCT06834035IV IgGUpdated May 5, 2026

Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa

A Phase 1/2 interventional study of Immunoglobulin G in Epidermolysis Bullosa, Epidermolysis Bullosa Acquisita and Dystrophic Epidermolysis Bullosa, sponsored by M. Peter Marinkovich. Recruiting at 1 site in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by M. Peter Marinkovich · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
6 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Epidermolysis Bullosa
  • Epidermolysis Bullosa Acquisita
  • Dystrophic Epidermolysis Bullosa
  • Recessive Dystrophic Epidermolysis Bullosa

Keywords

  • Epidermolysis Bullosa
  • Epidermolysis Bullosa Acquisita
  • Dystrophic Epidermolysis Bullosa
  • Recessive Dystrophic Epidermolysis Bullosa
  • Collagen 7
  • C7
  • Col7
  • EB
  • EBA
  • DEB
  • RDEB
  • Antibodies
  • Collagen VII
  • IV IgG
  • IgG
  • IVIgG
  • C7 Antibodies
  • Collagen 7 Antibodies
  • Collagen VII Antibodies
  • Vyjuvek
  • B-VEC
03

Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. History of thrombotic event(s)
  2. History of cardiac failure
  3. History of renal failure
  4. IgA deficiency
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • Experimental
    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.

    Biological: Immunoglobulin G

Interventions

  • BiologicalImmunoglobulin G

    Purified IgG from human serum, delivered via IV

    Also known as: IgG, IV IgG

05

What researchers measure

Primary outcomes

  1. Adverse Events and Effects

    Occurrence of adverse events and effects

    Time frame: 9 Months

  2. 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.

    Time frame: 9 Months

06

Study locations

1 of 1 sites recruiting
  • Stanford University
    Redwood City, California 94163, United States
    • Clinical Research Coordinator · Contact · cimino@stanford.edu · 650-723-3439
    • Matt P Marinkovich, MD · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT06834035
Lead sponsor
M. Peter Marinkovich
Collaborators
Epidermolysis Bullosa Research Partnership
Responsible party
M. Peter Marinkovich (Associate Professor of Dermatology, Stanford University) — Sponsor-investigator
First posted
Feb 19, 2025
Start date
Aug 4, 2025
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
May 5, 2026

Study contacts

Kunju Clinical Research Coordinator, PhD
Contact
kunju@stanford.edu
650-721-4902
Matt P Marinkovich, MD
principal investigator · Associate Professor of Dermatology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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