RECRUITING

Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa

Quick Facts

Study Start:2025-08-04
Study Completion:2026-03-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06834035

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.

Ages Eligible for Study:6 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations.
  2. 2. Diagnosis of EBA demonstrated by the presence of levels of serum C7 antibodies above the normal ELISA range
  3. 3. Baseline skin blistering greater than 5% total body surface area
  4. 4. 1 wound at least 20 cm\^2 able to be entirely treated with Vyjuvek weekly
  5. 5. 1 wound at least 20 cm\^2 that has never been treated with Vyjuvek
  6. 6. Ongoing VYJUVEK treatment.
  1. 1. History of thrombotic event(s)
  2. 2. History of cardiac failure
  3. 3. History of renal failure
  4. 4. IgA deficiency

Contacts and Locations

Study Contact

Clinical Research Coordinator
CONTACT
650-723-3439
cimino@stanford.edu
Clinical Research Coordinator
CONTACT
6507214902
kunju@stanford.edu

Principal Investigator

Matt P Marinkovich, MD
PRINCIPAL_INVESTIGATOR
Associate Professor of Dermatology

Study Locations (Sites)

Stanford University
Redwood City, California, 94163
United States

Collaborators and Investigators

Sponsor: M. Peter Marinkovich

  • Matt P Marinkovich, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2025-08-04
Study Completion Date2026-03-06

Study Record Updates

Study Start Date2025-08-04
Study Completion Date2026-03-06

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

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