Epidermolysis BullosaPhase 1/2IV IgGNCT06834035
Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa
A Phase 1/2 study testing Immunoglobulin G in people with Epidermolysis Bullosa and Epidermolysis Bullosa Acquisita, run by M. Peter Marinkovich at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Epidermolysis Bullosa, Epidermolysis Bullosa Acquisita, Dystrophic Epidermolysis Bullosa
- What is being tested?
- Immunoglobulin G
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2025to Mar 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of thrombotic event(s)
- History of cardiac failure
- History of renal failure
- IgA deficiency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Redwood City, California, 94163
Clinical Research Coordinator, 650-723-3439, cimino@stanford.edu
Matt P Marinkovich, MD
About this study
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.
- Conditions
- Epidermolysis Bullosa, Epidermolysis Bullosa Acquisita, Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa
- Being tested
- Immunoglobulin G
- Keywords
- Epidermolysis Bullosa, Epidermolysis Bullosa Acquisita, Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Collagen 7, C7, Col7, EB, EBA, DEB, RDEB, Antibodies, Collagen VII, IV IgG, IgG, IVIgG, C7 Antibodies, Collagen 7 Antibodies, Collagen VII Antibodies, Vyjuvek
- Medical subject headings
- Epidermolysis Bullosa, Epidermolysis Bullosa Acquisita, Epidermolysis Bullosa Dystrophica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoglobulin GBiological
Also called IgG, IV IgG
Purified IgG from human serum, delivered via IV
| Study group | Role | What they receive |
|---|---|---|
| Intra-Personal Control | Experimental | 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. Receives: Biological: Immunoglobulin G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events and Effects
Occurrence of adverse events and effects
Measured: 9 Months
Percent Change in Wound Area
The wound area at the end of the treatment phase compared to the wound area at the beginning of the treatment phase.
Wound healing (% and cm^2) over the course of the treatment phase compared to the wound healing (% and cm^2), over the observation phase.
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start4 Aug 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermolysis BullosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M. Peter Marinkovich
- Sponsor type
- University, hospital or other
- Collaborators
- Epidermolysis Bullosa Research Partnership
- Responsible party
- Sponsor-investigator, M. Peter Marinkovich, Stanford University
- Investigators
- Matt P Marinkovich, MD, Principal investigator, Associate Professor of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834035
- Sponsor's protocol ID
- 73958
- Acronym
- IV IgG
- Status last verified
- Apr 2026
- First submitted
- 13 Feb 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa
- ClinicalTrials.gov ID
- NCT06834035
- Acronym / sponsor ID
- IV IgG / 73958
- Conditions
- Epidermolysis Bullosa, Epidermolysis Bullosa Acquisita, Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa
- Keywords
- Epidermolysis Bullosa, Epidermolysis Bullosa Acquisita, Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Collagen 7, C7, Col7, EB
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- M. Peter MarinkovichUniversity, hospital or other
- Collaborators
- Epidermolysis Bullosa Research Partnership
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-Personal Control | Experimental | Biological: Immunoglobulin GThere 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- History of thrombotic event(s)
- History of cardiac failure
- History of renal failure
- IgA deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunoglobulin GAlso: IgG, IV IgGPurified IgG from human serum, delivered via IV | Biological | Intra-Personal Control |
Primary outcome
Adverse Events and Effects
Time frame: 9 Months
Occurrence of adverse events and effects
Percent Change in Wound Area
Time frame: 9 Months
The wound area at the end of the treatment phase compared to the wound area at the beginning of the treatment phase. Wound healing (% and cm^2) over the course of the treatment phase compared to the wound healing (% and cm^2), over the observation phase.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
Related trials for Epidermolysis Bullosa
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Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matt P Marinkovich, MD principal investigator
Associate Professor of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Immunoglobulin G in people with Epidermolysis Bullosa and Epidermolysis Bullosa Acquisita, run by M. Peter Marinkovich at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kunju Clinical Research Coordinator, PhD (650-721-4902, kunju@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events and Effects (time frame: 9 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.