Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa (IV IgG)

April 29, 2026 updated by: M. Peter Marinkovich

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

8

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kunju Clinical Research Coordinator, PhD
  • Phone Number: 650-721-4902
  • Email: kunju@stanford.edu

Study Locations

  • United States
    • California
      • Redwood City, California, United States, 94163
        • Recruiting
        • Stanford University
        • Contact:
        • Principal Investigator:
          • Matt P Marinkovich, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Purified IgG from human serum, delivered via IV
Other Names:
  • IgG
  • IV IgG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events and Effects
Time Frame: 9 Months
Occurrence of adverse events and effects
9 Months
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.
9 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M. Peter Marinkovich

Collaborators

Epidermolysis Bullosa Research Partnership

Investigators

  • Principal Investigator: Matt P Marinkovich, MD, Associate Professor of Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

February 19, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 73958

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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