A Phase 1/2 interventional study of Immunoglobulin G in Epidermolysis Bullosa, Epidermolysis Bullosa Acquisita and Dystrophic Epidermolysis Bullosa, sponsored by M. Peter Marinkovich. Recruiting at 1 site in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by M. Peter Marinkovich · Phase 1/2, Interventional, and Treatment
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Among 45 studies in Epidermolysis Bullosa Dystrophica with a site in United States — 12 open to participants now, 16 under way, 4 of them phase 3. Epidermolysis Bullosa Dystrophica · United States.
Among the 45 studies in Epidermolysis Bullosa Dystrophica with a site in United States, this one is the 16th largest by planned enrollment of the 32 interventional ones that give a count, is one of 4 that started in 2025, is one of 12 in phase 1/2, reaches primary completion later than 7 of the 15 other live ones, and was the 41st registered.
78 studies on the registry are indexed under Epidermolysis Bullosa Dystrophica; 21 are open to participants now.
Browse Epidermolysis Bullosa Dystrophica studies →12 of the 45 studies in Epidermolysis Bullosa Dystrophica with a site in United States are open now. Recruiting first, the newest first:
Xinnate AB · Sites in United States, France, Greece and 4 more countries
Ages 4+
Abeona Therapeutics, Inc · Sites in United States
Krystal Biotech, Inc. · Sites in United States
Ages 6 mo+
Chiesi Farmaceutici S.p.A. · Sites in United States, France, Germany and 3 more countries
Aegle Therapeutics · Sites in United States
Ages 6 mo+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 17 Epidermolysis Bullosa Dystrophica studies recruiting now, 13 (76%) set no upper age limit and 3 (18%) stop at 75 or younger; 15 take children under 18; 2 take healthy volunteers.
This study: 6 Years and older · all sexes · no healthy volunteers.
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45 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 18 · Phase 3 8
First in 2007; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 8 is below the median of 9 across 55 interventional studies indexed under Epidermolysis Bullosa Dystrophica.
Median enrollment 8 across the 32 interventional studies, 29 across the 13 observational. Of the 24 that completed or were terminated, 11 (46%) have results posted.
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29 of 45 have an industry lead sponsor. The 10 most frequent:
M. Peter Marinkovich is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
M. Peter Marinkovich has 2 studies filed under Epidermolysis Bullosa Dystrophica — fewer than ten, so there is no comparison to draw.
4 of the studies in Epidermolysis Bullosa Dystrophica with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07016750Phase 3Krystal Biotech, Inc.A Study Comparing KB803 and Matched Placebo in Patients With Dystrophic Epidermolysis Bullosa | 2026-12 |
| NCT06892639Phase 3Castle Creek Biosciences, LLC.Evaluation of D-Fi for the Treatment of Wounds Due to DEB | 2027-09 |
| NCT06834035M. Peter MarinkovichTargeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa | 2027-03 |
| NCT06594393Xinnate ABA Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study | 2027-06-30 |
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Among the 45 studies in Epidermolysis Bullosa Dystrophica with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
78 studies on the registry are indexed under Epidermolysis Bullosa Dystrophica; 21 are open to participants now.
This study's planned enrollment of 8 is below the median of 9 across 55 interventional studies indexed under Epidermolysis Bullosa Dystrophica.
Browse Epidermolysis Bullosa Dystrophica studies →M. Peter Marinkovich is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Compared within Epidermolysis Bullosa Dystrophica, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Epidermolysis Bullosa. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Biological: Immunoglobulin G
Purified IgG from human serum, delivered via IV
Also known as: IgG, IV IgG
Adverse Events and Effects
Occurrence of adverse events and effects
Time frame: 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.
Time frame: 9 Months
Started Aug 2025 (actual). Primary completion is estimated for Mar 2027, 19 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Immunoglobulin G
Epidermolysis Bullosa Dystrophica →
M. Peter Marinkovich