Efficacy, Safety and PK/PD of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN) (NewPLACE) (NewPLACE)
Efficacy, Safety and PK/PD of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN) (NewPLACE) (NewPLACE)
Brief Summary:
This 2-arm, multi-center, open-label, parallel-group phase II trial will assess the efficacy, safety and pharmacokinetics/pharmacodynamics of the human antibody MOR202 in subjects with anti-PLA2R antibody-positive membranous nephropathy indicated for immunosuppressive therapy
Detailed Description:
After treatment, subjects will enter a repeat treatment period (3 months) if necessary; and a final follow-up period of 15 to 18 months
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE)
Actual Study Start Date: January 20, 2021
Estimated Primary Completion Date: April 1, 2022
Estimated Study Completion Date: January 11, 2024
Arm:
- Experimental: MOR202 Arm 1
- Experimental: MOR202 Arm 2
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 22 |
| Actual Study start date | 20 January 2021 |
| Estimated Study Completion Date | 11 January 2024 |