This 2-arm, multi-center, open-label, parallel-group phase II trial will assess the efficacy, safety and pharmacokinetics/pharmacodynamics of the human antibody MOR202 in subjects with anti-PLA2R antibody-positive membranous nephropathy indicated for immunosuppressive therapy
After treatment, subjects will enter a repeat treatment period (3 months) if necessary; and a final follow-up period of 15 to 18 months. Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
MOR202 will be administered as an intravenous infusion
Managadze National Center of Urology
Tbilisi, Georgia
efficacy: percent change of anti-PLA2R antibody levels
efficacy of 2 different dosing regimens of MOR202 in subjects with anti-PLA2R antibody positive MN
Time frame: 3 months compared to baseline
efficacy: immunological complete response (ICR) rate
efficacy of 2 different dosing regimens of MOR202
Time frame: ICR rate at 3 months, 6 months, 12 months and 24 months
efficacy: overall proteinuria response (OPR) rate
efficacy of 2 different dosing regimens of MOR202
Time frame: OPR rate at 6 months, 12 months and 24 months.
safety: determined by the frequency, incidence and severity of TEAEs
frequency, incidence and severity of treatment-emergent adverse events
Time frame: through treatment completion, an average of 3 months per treatment period
PK profile
MOR202 serum concentrations after multiple i.v. administrations
Time frame: through study completion, an average of 1 year
immunogenicity
number of subjects developing anti-MOR202 antibodies
Time frame: through study completion, an average of 1 year
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