Anti-PLA2R antibody positive membranous nephropathy (aMN) MedDRA version: 21.1 Level: LLT Classification code 10027170 Term: Membranous nephropathy System Organ Class: 100000004857
Conditions
Sponsors
MorphoSys AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects = 18 to = 80 years (at date of signing the informed consent form [ICF]). 2. Urine protein to creatinine ratio (UPCR) of = 3.0 g/g (as determined by a 24 h urine collection) or proteinuria = 3.5 g/24 h (as determined by a 24 h urine collection) 3. Anti-PLA2R antibody positive MN in need for IST according to the investigator’s judgment. 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 to screening is acceptable. 4. Estimated glomerular filtration rate (eGFR) = 50 ml/min/1.73 m². Alternatively, subjects with an eGFR >30 and =65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: 1. Hemoglobin 20 mg prednisone/day) within 30 days prior to start of screening. b. Alkylating agents (e.g. cyclophosphamide) or calcineurin inhibitors (CNIs) (e.g. tacrolimus, cyclosporine A) within 90 days. c. Biologic drugs including rituximab (RTX) within 180 days. d. Any other oral/parenteral IST within 180 days. 12. Significant uncontrolled cardiovascular disease or cardiac insufficiency (New York Heart Association [NYHA] class IV) as judged by the investigator. 13. Clinically relevant findings on a 12-lead electrocardiogram (ECG) as determined by the investigator at screening. 14. History of significant cerebrovascular disease or sensory or motor neuropathy of toxicity = grade 3. 15. Total bilirubin, aspartate aminotransferase or alanine aminotransferase >1.5 x ULN, alkaline phosphatase >3.0 x ULN. 16. Known or suspected hypersensitivity to MOR202 and its excipients (L-histidine, sucrose, polysorbate 20). 17. All patients will be screened for HIV, HBsAg, HBsAb, HBcAb, HC Ab and Hepatitis C RNA. If a patient tests positive for any of the following: HIV, HBsAg, HBcAb or HC Ab or Hepatitis C RNA, then the patient should be excluded from the study. If a patient tests positive only for HBsAb, HBV-DNA should be tested and if this test result is positive the patient should be excluded from the study. Patients who test positive only for HBsAb and negative for HBV-DNA are eligible. 18. For any other pre-existing symptoms and impairments of health or any residual toxicity from prior therapy classified = grade 3 (NCI-CTCAE). 19. Any malignancy within 5 years prior to screening start, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non melanomatous skin cancer. 20. Treatment within 5 terminal half-lives (if known) or within the last 30 days prior to baseline (whatever is longer) with investigational drugs. 21. Any active infection (viral, fungal, bacterial) requiring systemic therapy. 22. Any other disease which, in the investigator’s opinion, is likely to compromise the subject’s ability to participate in the trial. 23. Not applicable to EU sites. 24. Individuals housed in institutions due to official or judicial orders or who are in positions of dependency vis-à-vis the sponsor or investigator are not eligible for participation. 25. History or current hemostasis or bleeding disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of 2 different dosing regimens of MOR202 in subjects with anti PLA2R antibody positive MN ;Secondary Objective: • To assess the efficacy of 2 different dosing regimens of MOR202 • To assess the safety of MOR202 • To assess the PK profile of MOR202 • To investigate the potential immunogenicity of MOR202 ;Primary end point(s): Percent change of anti-PLA2R antibody levels;Timepoint(s) of evaluation of this end point: 3 months compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Immunological complete response (ICR) rate • Overall proteinuria response (OPR) rate • Frequency, incidence and severity of treatment-emergent adverse events (TEAEs). • Serum concentrations of MOR202 over time. • Formation of anti drug antibodies. ;Timepoint(s) of evaluation of this end point: ICR: 3 months, 6 months, 12 months and 24 months OPR: 6 months, 12 months and 24 months Other time points are according to the Schedule of Activities in the study protocol | — |
Countries
France, Georgia, Germany, Greece, Hong Kong, Korea, Republic of, Russian Federation, Taiwan, United Kingdom
Contacts
Public ContactGlobal Program Medical Director
MorphoSys AG
Outcome results
None listed