Pemphigus Vulgaris Clinical Trial
Official title:
A Crossover, Randomized and Multi-center Study to Evaluate the Efficacy and Safety of Abatacept Versus Mycophenolate Mofetil (MMF) in Treatment of PV
Pemphigus vulgaris (PV) is a rare, chronic, debilitating, and potentially life-threatening autoimmune disorder that is characterized by mucocutaneous blisters.Abatacept is a biologic drug that belongs to the class of T-cell co-stimulation modulators and is used for the treatment of autoimmune diseases.
The background therapy is based on prednisolone administration. PV is a rare disorder, therefore this study is designed as a crossover that may require fewer patients than a parallel study. The study enrolled participants with moderate-to-severely active PV requiring ≥ 50 milligrams per day (mg/day) oral prednisone or equivalent. The purpose of this study was to evaluate the efficacy, tolerability, and safety of abatacept injection for subcutaneous use (abatacept SC) 150 mg administered once in a week in subjects with PV. It was anticipated that with sustained immune suppression in the presence of abatacept SC that clinical remission of the disease would be improved. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04422912 -
A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV)
|
Phase 1 | |
Recruiting |
NCT05635266 -
Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
|
||
Recruiting |
NCT04117529 -
Phenotypic and Functional Characterisation of Human B-cell Response in Pemphigus
|
N/A | |
Completed |
NCT03334058 -
A Study to Evaluate the Safety, PD, PK and Efficacy of ARGX-113 in Patients With Pemphigus
|
Phase 2 | |
Terminated |
NCT03239470 -
Polyclonal Regulatory T Cells (PolyTregs) for Pemphigus
|
Phase 1 | |
Completed |
NCT00606749 -
Use of KC706 for the Treatment of Pemphigus Vulgaris
|
Phase 2 | |
Terminated |
NCT00429533 -
Efficacy of Dapsone as a Steroid Sparing Agent in Pemphigus Vulgaris
|
Phase 2 | |
Recruiting |
NCT05594472 -
Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid
|
Phase 3 | |
Completed |
NCT02383589 -
A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV)
|
Phase 3 | |
Withdrawn |
NCT03780166 -
A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris
|
Phase 2 | |
Recruiting |
NCT04096222 -
Comparative Analysis of the Th17 Cellular Response in Active and Inactive Pemphigus Vulgaris Patients
|
||
Not yet recruiting |
NCT03177213 -
Serum IL-21 Levels in Patients With Pemphigus Vulgaris
|
N/A | |
Completed |
NCT00135720 -
Study of Etanercept (Enbrel) in the Treatment of Pemphigus Vulgaris
|
Phase 2 | |
Completed |
NCT00063752 -
Safety Study of PI-0824 to Treat Pemphigus Vulgaris
|
Phase 1 | |
Terminated |
NCT03075904 -
A Safety and Dose-Finding Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus)
|
Phase 1/Phase 2 | |
Terminated |
NCT04598477 -
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)
|
Phase 3 | |
Completed |
NCT02704429 -
A Study of PRN1008 in Adult Patients With Pemphigus Vulgaris
|
Phase 2 | |
Completed |
NCT00626678 -
Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone
|
Phase 2 | |
Active, not recruiting |
NCT05338112 -
Role of Tzanck Smear in Determining Pemphigus Vulgaris Disease Activity
|
||
Completed |
NCT06167408 -
Identifying Factors Influencing In-Hospital Relapse in Pemphigus Patients
|