NCT06834035 Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa
| NCT ID | NCT06834035 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | M. Peter Marinkovich |
| Condition | Epidermolysis Bullosa |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2025-08-04 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 8 participants in total. It began in 2025-08-04 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Matt P Marinkovich, MD
PRINCIPAL INVESTIGATOR
Associate Professor of Dermatology
Frequently Asked Questions
Who can join the NCT06834035 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, studying Epidermolysis Bullosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06834035 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06834035 currently recruiting?
Yes, NCT06834035 is actively recruiting participants. Contact the research team at kunju@stanford.edu for enrollment information.
Where is the NCT06834035 trial being conducted?
This trial is being conducted at Redwood City, United States.
Who is sponsoring the NCT06834035 clinical trial?
NCT06834035 is sponsored by M. Peter Marinkovich. The principal investigator is Matt P Marinkovich, MD at Associate Professor of Dermatology. The trial plans to enroll 8 participants.