Using IV immunoglobulin to lower collagen VII antibodies in dystrophic epidermolysis bullosa
Official title: Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa
Run by Stanford University · NCT06834035 · Data updated 2026-11-12
This trial tests whether IV immunoglobulin given to people with recessive dystrophic epidermolysis bullosa who are on VYJUVEK helps wounds heal faster and lowers collagen VII and HSV‑1 antibody levels.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 6 Years and up |
| Sex | All |
| Enrollment | 8 (estimated) |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Redwood City, California) |
| Status | Recruiting |
| Started | August 4, 2025 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT06834035 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with genetically confirmed generalized RDEB (COL7A1 mutations) who have >5% body surface blistering, are already on ongoing VYJUVEK treatment, and have one wound ≥20 cm² treated with VYJUVEK and another ≥20 cm² never treated with VYJUVEK.
✕Probably not a fit
Patients with a history of thrombotic events, cardiac or renal failure, IgA deficiency, or those not meeting the VYJUVEK and wound-size requirements are unlikely to benefit or to be eligible for this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1/2 interventional study gives intravenous immunoglobulin (IVIG) to people with recessive dystrophic epidermolysis bullosa (RDEB) who are already receiving VYJUVEK to see if adding IVIG improves wound healing and changes serum levels of collagen VII (C7) and HSV‑1 antibodies. Eligible participants must have confirmed COL7A1 mutations, baseline skin blistering greater than 5% total body surface area, and two qualifying wounds (one treated weekly with VYJUVEK and one never treated with VYJUVEK). The study measures wound healing outcomes and antibody levels over time after IVIG infusions. The intervention is administered at Stanford University (Redwood City, CA) under a Phase 1/2 protocol.
Why it matters
Potential benefit: If successful, patients could experience fewer and faster-healing wounds and lower harmful antibody levels, which may reduce pain, infection risk, and improve quality of life.
How similar studies have gone: IVIG has shown benefit in other antibody-mediated blistering diseases, but using IVIG specifically to reduce anti-C7 antibodies in RDEB alongside VYJUVEK is a relatively novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Stanford University
Redwood City, California, United States Recruiting
Study contacts
- Principal investigator: Matt P Marinkovich, MD — Associate Professor of Dermatology
- Study coordinator: Kunju Clinical Research Coordinator, PhD
- Email: kunju@stanford.edu
- Phone: 650-721-4902
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.