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

MorphoSys AG0 sites30 target enrollmentOctober 15, 2019

ConditionsPrimary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1 Level: LLT Classification code 10027170 Term: Membranous nephropathy System Organ Class: 100000004857 Therapeutic area: Body processes [G] - Immune system processes [G12]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Primary (anti-PLA2R antibody positive) Membranous Nephropathy
Sponsor: MorphoSys AG
Enrollment: 30
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 15, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

MorphoSys AG

Eligibility Criteria

Inclusion Criteria

•1\. \=18 to \=80 years (at date of signing ICF)
•2\. Urine protein to creatinine ratio (UPCR) of \= 3\.0 g/g (as measured from a 24 hour urine collection)
•3\. MN diagnosed on the basis of a 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 range without availability of an adequate biopsy, a biopsy at screening should be performed for IFTA assessment.
•5\. The subject is on supportive treatment with an ACEI or an ARB for at least 4 weeks prior to screening. The ACEI or ARB treatment should have reached a stable dose according to best local practice.
•6\. Systolic BP \= 150 mmHg and diastolic BP \= 100 mmHg after a period of 5 minutes of rest as measured at screening
•7\. Subject vaccinated against Pneumococcus within the last 3 years prior to date of signing ICF (subjects may be vaccinated during screening to meet this criterion; interval to first dose of MOR202 must be at least 14 days (1\)).
•8\. Cohort 1: Serum anti\-PLA2R antibodies \= 150\.0 RU/mL as determined at screening by Euroimmun ELISA
•9\. Cohort 1: Serum anti\-PLA2R antibodies before screening ris\-ing or stable as judged by the investigator
•10\. Cohort 1, relapse subjects only: Must have had complete remission of proteinuria, or a combination of partial remission of proteinuria (demonstrating at least 50 % decrease) with a remission of serum anti\-PLA2R anti\-body titer to less than 20\.0 RU/mL (Euroimmun ELISA) or negative Immunfluorescence Test (IFT). Remission must have lasted for at least 6 months according to clinical judgement.

Exclusion Criteria

•1\. Hemoglobin \< 90 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 \=5\.0 g/L
•6\. Secondary cause of MN (e.g. SLE, medications, malignancies) as determined by the investigator
•7\. Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus nephritis, IgA nephropathy)