Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa

Part of paid clinical trials in Redwood City, California.

Sponsor
M. Peter Marinkovich
Study ID
NCT06834035
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Immunoglobulin G — BIOLOGICAL
    Purified IgG from human serum, delivered via IV

Study Details

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.

Key Dates

Start date
Aug 4, 2025
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Adverse Events and Effects [ Time Frame: 9 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityRedwood CityCalifornia94163
Clinical Research Coordinator
[email protected]
650-723-3439
Matt P Marinkovich, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Redwood City, CA

By research site
Stanford University· Redwood City, CA

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