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New treatment option for Epidermolysis Bullosa
Official title Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa
ClinicalTrials.gov ID: NCT06834035
What this study is testing
What is Immunoglobulin G?
Immunoglobulin G is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for epidermolysis bullosa.
Also referred to as IgG, IV IgG.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older
You may be able to join if
- Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations.
- Diagnosis of EBA demonstrated by the presence of levels of serum C7 antibodies above the normal ELISA range
- Baseline skin blistering greater than 5% total body surface area
- 1 wound at least 20 cm\^2 able to be entirely treated with Vyjuvek weekly
- 1 wound at least 20 cm\^2 that has never been treated with Vyjuvek
You likely can't join if
- History of thrombotic event(s)
- History of cardiac failure
- History of renal failure
- IgA deficiency
See the full eligibility criteria
- Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations.
- Diagnosis of EBA demonstrated by the presence of levels of serum C7 antibodies above the normal ELISA range
- Baseline skin blistering greater than 5% total body surface area
- 1 wound at least 20 cm\^2 able to be entirely treated with Vyjuvek weekly
- 1 wound at least 20 cm\^2 that has never been treated with Vyjuvek
- Ongoing VYJUVEK treatment.
- History of thrombotic event(s)
- History of cardiac failure
- History of renal failure
- IgA deficiency
The study team makes the final eligibility decision.
Where it's taking place
- Redwood City, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Redwood City, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.