Targeting Collagen VII Antibodies in Bullous Diseases Using Efgartigimod IV (VYVGART)

Part of paid clinical trials in Redwood City, California.

Sponsor
M. Peter Marinkovich
Study ID
NCT07011589
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Dystrophic Epidermolysis Bullosa
  • Epidermolysis Bullosa (EB)
  • Epidermolysis Bullosa Acquisita
  • Recessive Dystrophic Epidermolysis Bullosa

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Efgartigimod — BIOLOGICAL
    Dosage: 10mg/kg Frequency: Once a week Duration: 25 weeks

Study Details

The study objective is to see if IV Efgartigimod and Vyjuvek treatment in Recessive Dystrophic Epidermolysis Bullosa (RDEB) and IV Efgartigimod treatment in Epidermolysis Bullosa Acquisita (EBA) improves wound healing and affects the levels of C7 antibody levels in serum. Fewer wounds, more rapidly healing wounds, and decreased C7 antibodies could improve quality of life.

Key Dates

Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Efgartigimod
    There is one arm of the study. First, each participant undergoes a 3-month observational period. If the participant has DEB, they will continue their standard of care VYJUVEK as prescribed. After the observational period concludes, the participant enters the treatment period, during which Efgartigimod is administered. DEB participants will continue their standard of care VYJUVEK as prescribed.

Primary Outcome Measure

Reduction in serum C7 antibody levels [ Time Frame: 26 weeks ]

Central Contacts

  • Kunju Clinical Research Coordinator, PhD
    650-721-4902
    [email protected]
  • Clinical Research Coordinator

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityRedwood CityCalifornia94163
Clinical Research Coordinator
[email protected]
650-723-3439
Clinical Research Coordinator
[email protected]
6507214902
Matt P Marinkovich, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Stanford University· Redwood City, CA

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