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 enrollmentSeptember 14, 2020

ConditionsPrimary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1Level: LLTClassification code 10027170Term: Membranous nephropathySystem 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: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 14, 2020

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

MorphoSys AG

Eligibility Criteria

Inclusion Criteria

•1\. \=18 to \=80 years, at date of signing informed consent form (ICF).
•2\. Urine protein to creatinine ratio (UPCR) of \= 3\.0000 g/g OR proteinuria \= 3\.500g/24 h from 24\-h urine at screening.
•3\. Anti\-PLA2R antibody positive MN in need for IST according to investigator's judgement. The diagnosis of MN should be histologically documented with a diagnostic biopsy; for this purpose, a biopsy at screening or an archival biopsy acquired within 5 years prior screening is acceptable.
•4\.Estimated glomerular filtration rate (eGFR) \= 50 mL/min/1\.73m². Alternatively eGFR \=30 and \<50 mL/min/1\.73m² and interstitial fibrosis and tubular atrophy (IFTA) score \< 25% in a renal biopsy obtained within the last 6 months prior to start of screening (if not available, a biopsy should be performed at screening to obtain the IFTA assessment).
•5\. Not in spontaneous remission despite proper treatment with ACEIs, ARBs (sufficient dose and treatment duration) as per clinical practice and guidelines. If the PI determines that a subject is intolerant to an ACEI or ARB, the reason must be documented and approval obtained from the Medical Monitor prior to enrolment.
•6\. Systolic BP \= 150 mmHg and diastolic BP \= 100 mmHg after a period of 5 minutes rest.
•7\. Subject vaccinated against Pneumococcus within the last 5 years prior to date of signing ICF (subjects may be vaccinated during screening to meet this criterion during screening; interval to first dose of MOR202 must be at least 14 days \[MSD SmPC]).
•8\. Cohort 1 comprises newly or relapsed subjects: Serum anti\-PLA2R antibodies \=50\.0 RU/ml determined by Euroimmun ELISA at central laboratory.
•9\. Cohort 2 comprises therapy refractory subjects:
•a. subject did not achieve immunological remission after prior IST(s) as documented by the investigator AND

Exclusion Criteria

•1\.Hemoglobin \< 80 g/L
•2\.Thrombocytopenia: Platelets \< 100\.0 × 109/L
•3\.Neutropenia: Neutrophils \< 1\.5 × 109/L
•4\.Leukopenia: Leukocytes \< 3\.0 × 109/L
•5\.Hypogammaglobulinemia defined as serum immunoglobulin \= 4\.0 g/L
•6\.B\-cells \< 5 × 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).
•9\.Diabetes mellitus type 1\.
•10\.Diabetes mellitus type 2: Subjects with type 2 diabetes mellitus may only enter the clinical trial if a kidney biopsy performed within 6 months prior to screening shows MN without evidence of diabetic nephropathy and their disease is controlled, such as: