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Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

8 Participants Needed

IV IgG for Dystrophic Epidermolysis Bullosa
(IV IgG Trial)

Overseen ByClinical Research Coordinator

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: M. Peter Marinkovich

Must be taking: Vyjuvek

Disqualifiers: Thrombotic events, Cardiac failure, Renal failure, IgA deficiency

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, ongoing VYJUVEK treatment is required for participation.

What data supports the effectiveness of the treatment IV IgG for Dystrophic Epidermolysis Bullosa?

Research on similar conditions, like epidermolysis bullosa acquisita, shows that IV IgG can help reduce disease severity and improve symptoms when other treatments fail. It has been effective in reducing skin inflammation and improving patient outcomes in these cases.¹ ² ³ ⁴ ⁵

How does the drug IV IgG differ from other treatments for Dystrophic Epidermolysis Bullosa?

IV IgG (intravenous immunoglobulin) is unique because it involves administering antibodies directly into the bloodstream, which can help modulate the immune system. This approach is different from other treatments that might focus on topical care or wound management, as it targets the underlying immune response.⁶ ⁷ ⁸ ⁹ ¹⁰

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.

Research Team

Matt P Marinkovich, MD

Principal Investigator

Associate Professor of Dermatology

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.

See 3 more

Exclusion Criteria

I have had blood clots in the past.

I have IgA deficiency.

I have a history of heart failure.

See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational

Participants undergo a 3-month observational period, continuing their prescribed Vyjuvek application

12 weeks

Treatment

Participants continue Vyjuvek application and receive IV IgG treatment

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

IV IgG

Trial Overview 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.

Participant Groups

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.