Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This is an open-label, multicentre study to characterize the safety and efficacy of the human
anti-CD38 antibody MOR202 in adult subjects with in Anti-PLA2R Antibody Positive Membranous
Nephropathy (newly diagnosed/relapsed/refractory)
Phase
Phase 1/Phase 2
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
Key Inclusion Criteria:
- > 18 to < 80 years (at date of signing informed consent form [ICF]).
- Urine protein to creatinine ratio (UPCR) of ≥ 3.000 g/g OR proteinuria ≥ 3.500 g/24 h
from 24-h urine at screening
- Active anti-PLA2R antibody positive MN in need of immunosuppressive therapy (IST)
according to investigator judgement and diagnosed on the basis of a biopsy, archival
biopsy acquired within 5 years prior to screening is acceptable.
- Estimated glomerular filtration rate ≥ 50 ml/min/1.73m² or ≥ 30 and <50 ml/min/1.73m²,
and interstitial fibrosis and tubular atrophy score of less than 25% on a renal biopsy
obtained within the last 6 months prior to start of screening.
- Not in spontaneous remission despite proper treatment with ACEIs, ARBs (sufficient
dose and treatment duration) as per clinical practice and scientific guidelines. If
the subject is intolerant to an ACEI or ARB, the reason must be documented and
approval obtained prior to enrolment.
- Systolic blood pressure BP ≤150 mmHg and diastolic BP ≤100 mmHg after 5 minutes of
rest
- Vaccinated against Pneumococcus within the last 3 years prior to date of signing
informed consent (subjects may be vaccinated during screening to meet this criterion;
interval to first dose of MOR202 must be at least 14 days).
- Cohort 1 comprises newly diagnosed or relapsed subjects: Serum anti-PLA2R antibodies
≥50.0 RU/mL
- Cohort 2 comprises therapy refractory subjects: a Subject did not achieve
immunological remission after prior IST(s) as documented by the investigator AND b
Subject is without promising standard therapeutic options as documented by the
investigator (i.e. investigator expects efficacy or safety issues with remaining IST
options) AND c Serum anti-PLA2R antibodies ≥ 20.0 RU/mL measured at screening
Note: France will only enroll patients in Cohort 2.
Key Exclusion Criteria:
- Hemoglobin < 80 g/L.
- Thrombocytopenia: Platelets < 100.0 x 109/L.
- Neutropenia: Neutrophils < 1.5 x 109/L.
- Leukopenia: Leukocytes < 3.0 x 109/L.
- Hypogammaglobulinemia: Serum immunoglobulins ≤ 4.0 g/L.
Subjects may receive supportive therapies to meet the above criteria
- B-cells < 5 x 106/L.
- Secondary cause of MN (e.g. Systemic lupus erythematosus, medications, malignancies)
- Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus
nephritis, IgA nephropathy).