Targeting Collagen VII Antibodies with IV IgG in Dystrophic Epidermolysis Bullosa

Phase 1

Not yet recruiting

• Conditions: Epidermolysis Bullosa; Epidermolysis Bullosa Acquisita; Dystrophic Epidermolysis Bullosa; Recessive Dystrophic Epidermolysis Bullosa
• Interventions: Biological: Immunoglobulin G

• Registration Number: NCT06834035
• Lead Sponsor: M. Peter Marinkovich

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-13
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Study Start: 2025-03-06
• Primary Completion: 2026-03-06
• Study Completion: 2026-03-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intra-Personal Control	Immunoglobulin G	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.

Primary Outcome Measures

Name	Time	Method
Adverse Events and Effects	9 Months	Occurrence of adverse events and effects
Percent Change in Wound Area	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Redwood City, California, United States