Pemphigus Vulgaris Clinical Trial
Official title:
A Phase 1B/2, Multicenter, Open-Label, Safety, and Dose-Finding Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus)
This was a multicenter, open-label safety study to determine the dose regimen of SYNT001 (ALXN1830) administered intravenously in participants with pemphigus (vulgaris or foliaceus).
This study planned to evaluate 2 cohorts: up to 8 participants to receive 5 weekly
intravenous (IV) doses of ALXN1830 at 10 milligram/kilogram (mg/kg) (Cohort 1) and up to 12
participants to receive 3 x 30 mg/kg weekly doses of ALXN1830 IV (loading) followed by 5 x 10
mg/kg doses of ALXN1830 IV every other week or 10 weekly doses of ALXN1830 IV (maintenance)
(Cohort 2).
This study was terminated after the safety, tolerability, pharmacokinetics (PK),
pharmacodynamics (PD), and efficacy were characterized in participants with pemphigus at a
single dose level (10 mg/kg) in Cohort 1, before any participants were enrolled in Cohort 2.
The study consisted of 3 periods: Screening, Treatment, and Follow-Up.
;
| 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| Withdrawn |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 |
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
|
||
| Recruiting |
NCT05303272 -
A Study to Evaluate Efficacy and Safety of Abatacept in Participants of Pemphigus Vulgaris (PV)
|
Phase 4 |