A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Anti-body Positive Membranous Nephropathy (aMN) - M-PLACE - M-PLACE - MOR202

MorphoSys AG0 sites2 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•1\. \*18 to \*80 years (at date of signing ICF)
•2\. Urine protein to creatinine ratio (UPCR) of \* 3\.0000 g/g OR proteinuria \*
•3\.500 g/24 h from 24\-hr urine at screening
•3\. Active and anti\-PLA2R antibody positive MN in need for IST according to
•investigator judgement and with diagnostic biopsy, archival biopsy
•acquired within 5 years prior to screening is acceptable
•4\. Estimated glomerular filtration rate (eGFR) \*50 ml/min/1\.73m² or \>30 and \<50
•ml/min/1\.73m², and IFTA (interstitial fibrosis and tub\-ular
•atrophy) score of less than 25% on a renal biopsy obtained within the last 6
•months prior to start of screening. If a subject falls into the latter

•1\. Hemoglobin \< 80 g/L
•2\. Thrombocytopenia: Platelets \< 100\.0x10^9/L
•3\. Neutropenia: Neutrophils \< 1\.5x10^9/L
•4\. Leukopenia: Leukocytes \< 3\.0x10^9/L
•5\. Hypogammaglobulinemia: Serum immunoglobulins \*4\.0 g/L
•6\. B\-cells \< 5 x 106/L
•7\. Secondary cause of MN (e.g. SLE, medications, malignancies) as determined by
•the investigator
•8\. Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus
•nephritis, IgA nephropathy)

Not specified