NCT04145440

Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN)

A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (aMN)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: HI-Bio, A Biogen Company · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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)

Detailed description

After treatment subjects will be observed for up to 1 year. Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.

Conditions

• Glomerulonephritis, Membranous
• antiPLA2R Positive

Interventions

Type	Name	Description
DRUG	MOR202	Patients received 9 doses of MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occured weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.

Timeline

• Start date: 2019-10-15
• Primary completion: 2022-01-19
• Completion: 2022-08-02
• First posted: 2019-10-30
• Last updated: 2025-02-24
• Results posted: 2024-12-24

Locations

45 sites across 9 countries: United States, Australia, Belgium, France, Italy, Netherlands, Poland, South Korea, Spain

Regulatory

• FDA-regulated drug study