IV IgG for Dystrophic Epidermolysis Bullosa
(IV IgG Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMatt P Marinkovich, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: M. Peter Marinkovich

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals with Recessive Dystrophic Epidermolysis Bullosa (RDEB), a rare skin condition. Participants should have active wounds that could potentially heal better with treatment. Specific eligibility criteria are not provided, but typically include age, health status, and disease severity.

Inclusion Criteria

I have skin blistering covering more than 5% of my body.

I have a wound larger than 20 cm^2 that can be treated weekly.

My tests show high levels of C7 antibodies, indicating EBA.

+3 more

Exclusion Criteria

I have had blood clots in the past.

I have IgA deficiency.

I have a history of heart failure.

+1 more

Participant Groups

The trial tests if IV IgG can improve wound healing in RDEB patients when used alongside VYJUVEK therapy. It also examines the effect on C7 and HSV-1 antibody levels in the blood which may indicate improved skin health.

1Treatment groups

Experimental Treatment

Group I: Intra-Personal ControlExperimental Treatment1 Intervention

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.