Recruiting
Phase 1
Phase 2

IV IgG & VYJUVEK

Sponsor:

M. Peter Marinkovich

Code:

NCT06834035

Conditions

Epidermolysis Bullosa

Epidermolysis Bullosa Acquisita

Dystrophic Epidermolysis Bullosa

Recessive Dystrophic Epidermolysis Bullosa

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Interventions

Immunoglobulin G

Study Details

Brief 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.

Conditions

Epidermolysis Bullosa

Epidermolysis Bullosa Acquisita

Dystrophic Epidermolysis Bullosa

Recessive Dystrophic Epidermolysis Bullosa

Study ID

NCT06834035

Start date

Aug 4, 2025

Status verified date

Apr, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

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 Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Immunoglobulin G

Purified IgG from human serum, delivered via IV

Primary outcome measure

  • Adverse Events and Effects [ Time Frame: 9 Months ]
  • Percent Change in Wound Area [ Time Frame: 9 Months ]

Central Contacts and Locations

Central contacts

Kunju Clinical Research Coordinator, PhD

650-721-4902kunju@stanford.edu

Locations

Stanford University

Recruiting

Redwood City, California, United States, 94163

Contacts

Clinical Research Coordinator

650-723-3439cimino@stanford.edu

Principal Investigator:

Matt P Marinkovich, MD

More Information

Sponsor

M. Peter Marinkovich

Last update posted

May 5, 2026

Last verified

Apr, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M. Peter Marinkovich on 2026-05-05.