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Targeting Collagen VII Antibodies in Bullous Diseases Using Efgartigimod IV (VYVGART) | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

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

NCT07011589•M. Peter Marinkovich

Summary

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For DEB patients (aged 12 years or older): DEB confirmed with mutation analysis and correlated by phenotype, and treatment of at least 1 wound treated with topical gene therapy (VYJUVEK). Presence of C7 antibodies above normal cutoff on ELISA.
•For (classic) EBA patients (aged 18 years or older): EBA confirmed with positive histopathology (DIF), C7 antibodies above normal cutoff on ELISA, and having at least 1 skin lesion.
•The participant has a Karnofsky performance status of at least 60% at screening.
•Contraceptive use by reproductive male and female patients should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and:
•1. Male participants:
•\- Must agree to use an acceptable method of contraception and not donate sperm from the time that the ICF is signed until they have received their last dose of IMP.
•2. Female participants:
•* Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at week 1 / baseline before study intervention can be administered. Subsequent urine pregnancy tests are to be completed at week 6, week 11, week 16, week 21, and week 26 / EoS.
•* WOCBP must agree to use a highly effective or acceptable contraception method until at least 90 days after they receive their last dose of IMP.

Exclusion Criteria

•Linear IgA dermatosis-like EBA or other autoimmune blistering diseases (including but not limited to pemphigus vulgaris, bullous pemphigoid, mucous membrane pemphigoid).
•Use of the following EBA treatments:
•* sulfasalazine, IVIg, subcutaneous administration of immunoglobulin (SCIg), immunoadsorption or plasma exchange within 2 weeks of the screening visit, tetracyclines with or without nicotinamide at doses higher than the recommended daily allowance (RDA)/dietary reference intake (DRI) within 2 weeks of the screening visit.
•* any monoclonal antibody (including rituximab or another anti-CD20 biologic) within 6 months of the screening visit.
•* complementary therapies-such as traditional Chinese medicines, herbs, or procedures (e.g., acupuncture)-within 4 weeks (or 5 half-lives) of the screening visit, if the investigator determines that such therapies may interfere with the study's efficacy assessments and/or potentially risk the safety of the participant.
•* The use of the following EBA treatments is permitted throughout the study: OCS, topical corticosteroids, conventional immunosuppressants (e.g., azathioprine, cyclophosphamide, methotrexate, mycophenolate, or mofetil), and dapsone.
•Moderate to severe renal insufficiency.
•Known contraindication to OCS therapy.
•Clinically significant uncontrolled active or chronic, bacterial, viral, or fungal infection at screening
•Medical instability limiting ability to travel to the Investigative Center
+9 more criteria

Locations (1)

Stanford University

Redwood City, California, United States

Key Dates

Start Date

July 1, 2025

Primary Completion Date

July 1, 2026

Completion Date

October 1, 2026

Last Updated

June 9, 2025

Enrollment

ESTIMATED participants

Conditions

Epidermolysis Bullosa (EB)Epidermolysis Bullosa AcquisitaRecessive Dystrophic Epidermolysis BullosaDystrophic Epidermolysis Bullosa

Interventions

Efgartigimod

BIOLOGICAL

Contacts

Clinical Research Coordinator

CONTACT

650-723-3439 cimino@stanford.edu

Clinical Research Coordinator

CONTACT

16507214902 kunju@stanford.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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