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Clinical trial

Efficacy, Safety and PK/PD of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN) (NewPLACE) (NewPLACE)

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Last updated:28th Oct 2021
Status: Recruiting
Identifier: NCT04733040
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

- 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

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