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NCT Number: NCT06834035

Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa

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.

Recruiting

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Key information

Conditions

Epidermolysis Bullosa Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Dystrophic Epidermolysis Bullosa Epidermolysis Bullosa Acquisita Epidermolysis Bullosa Dystrophica Genetic Diseases, Inborn Recessive Dystrophic Epidermolysis Bullosa Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Stanford University

Redwood City, California, 94163, United States

Location status: Recruiting

Location contact

Clinical Research Coordinator

CONTACT

[email protected]

650-723-3439

Matt P Marinkovich, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • History of thrombotic event(s)
  • History of cardiac failure
  • History of renal failure
  • IgA deficiency

Treatment and study plan

Immunoglobulin G

Biological

Purified IgG from human serum, delivered via IV

Other names: IgG, IV IgG

Primary outcomes

  1. Adverse Events and Effects

    Time frame: 9 Months

    Occurrence of adverse events and effects

  2. Percent Change in Wound Area

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kunju Clinical Research Coordinator, PhD

CONTACT

[email protected]

650-721-4902

Sponsors and collaborators

Lead sponsor

M. Peter Marinkovich

Other

Collaborators

  • Epidermolysis Bullosa Research Partnership

Registry information

Acronym: IV IgG

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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