NCT04733040

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

A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: HI-Bio, A Biogen Company · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Glomerulonephritis
• Membranous Nephropathy
• antiPLA2R Positive

Interventions

Type	Name	Description
DRUG	MOR202	MOR202 will be administered as an intravenous infusion

Timeline

• Start date: 2021-01-20
• Primary completion: 2023-12-14
• Completion: 2023-12-14
• First posted: 2021-02-01
• Last updated: 2025-02-07

Locations

25 sites across 7 countries: Georgia, Germany, Greece, Russia, South Korea, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study