Targeting Collagen VII Antibodies in Bullous Diseases Using Efgartigimod IV (VYVGART)
NCT07011589 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2026-05-05
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.
Conditions
- Epidermolysis Bullosa (EB)
- Epidermolysis Bullosa Acquisita
- Recessive Dystrophic Epidermolysis Bullosa
- Dystrophic Epidermolysis Bullosa
Interventions
- BIOLOGICAL
-
Efgartigimod
Dosage: 10mg/kg Frequency: Once a week Duration: 25 weeks
Sponsors & Collaborators
- collaborator INDUSTRY
-
M. Peter Marinkovich
lead OTHER
Principal Investigators
-
Matt P Marinkovich, MD · Associate Professor of Dermatology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2028-01-31
- Completion
- 2028-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa
NCT04213261 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Evaluation of D-Fi for the Treatment of Wounds Due to DEB
NCT06892639 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
CACIPLIQ20 in Wound Healing in Subjects With Epidermolysis Bullosa
NCT06007235 ·Status: RECRUITING ·Phase: NA
-
Characteristics of Adult Patients With Recessive Dystrophic Epidermolysis Bullosa
NCT00904163 ·Status: COMPLETED
-
A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB)
NCT02810951 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Allogeneic ABCB5-positive Stem Cells for Treatment of Epidermolysis Bullosa
NCT03529877 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Rigosertib for RDEB-SCC
NCT03786237 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa
NCT01263379 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Evaluation of the Safety and Efficacy Study of RGN-137 Topical Gel for Junctional and Dystrophic Epidermolysis Bullosa
NCT03578029 ·Status: TERMINATED ·Phase: PHASE2
-
Study of Immune Tolerance and Capacity for Wound Healing of Patients With Recessive Dystrophic Epidermolysis Bullosa (RDEB)
NCT01874769 ·Status: COMPLETED
-
Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis
NCT02037347 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Efficacy of Granulocyte Colony Stimulating Factor (GCSF) In Patients With Dystrophic Epidermolysis Bullosa
NCT01538862 ·Status: COMPLETED ·Phase: PHASE2
-
Intravenous Gentamicin Therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB)
NCT03392909 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa
NCT05157958 ·Status: RECRUITING ·Phase: PHASE2
-
A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa
NCT06917690 ·Status: RECRUITING ·Phase: PHASE3
-
Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis
NCT00043706 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Vitiligo, New Treatment and Serum s100B
NCT06768840 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Study of the Blood and Skin Immunological Profile of Patients With Recessive Dystrophic Epidermolysis Bullosa: in Vivo Analysis and the Impact of Placental Stem Cells in Vitro
NCT06177353 ·Status: RECRUITING
-
Autologous Transplantation of Cultured Fibroblast on Amniotic Membrane in Patients With Epidermolysis Bullosa
NCT01908088 ·Status: COMPLETED ·Phase: PHASE1
-
Phase II Pilot Study of Extracorporeal Phototherapy for Epidermolysis Bullosa Acquisita
NCT00004359 ·Status: COMPLETED ·Phase: PHASE2
-
A Study in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung Function and Other Systemic Sclerosis Symptoms
NCT05559580 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of PTR-01 in Recessive Dystrophic Epidermolysis Bullosa
NCT04599881 ·Status: COMPLETED ·Phase: PHASE2
-
Short Term Observational Study in DEB Patients
NCT02178969 ·Status: COMPLETED
-
Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin
NCT06731933 ·Status: RECRUITING ·Phase: PHASE2
-
ERASE VITILIGO Early Repigmentation Approach for Stopping the Evolution of VITILIGO Prospective Multicentric Interventional Study With Blinded Evaluation
NCT04843059 ·Status: COMPLETED ·Phase: NA