Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa

Phase 2RecruitingNCT06834035

M. Peter Marinkovich8 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Adverse Events and Effects

Occurrence of adverse events and effects

Time frame: 9 Months

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

Central Contacts

Clinical Research Coordinator

CONTACT

650-723-3439 cimino@stanford.edu