CompletedPhase 2

Efficacy, Safety and PK/PD of MOR202 in Anti-PLA2R+ Membranous Nephropathy (aMN) (NewPLACE)

Georgia, Germany24 participantsStarted 2021-01-20

Plain-language summary

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

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Not a female of childbearing potential (FCBP)
✓. A FCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of MOR202

Exclusion criteria

✕. Glycated hemoglobin (HbA1c) \<8.0 % or 64 mmol/mol.
✕. No diabetic retinopathy known.
✕. No peripheral neuropathy known.

What they're measuring

efficacy: percent change of anti-PLA2R antibody levels

Timeframe: 3 months compared to baseline

Trial details

NCT IDNCT04733040

SponsorHI-Bio, A Biogen Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-14

View on ClinicalTrials.gov More Glomerulonephritis trials