NCT05065970

Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy

A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: HI-Bio, A Biogen Company · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Randomized, placebo-controlled, multi-center, double-blind, proof of concept phase IIa trial and dose evaluation trial of felzartamab in IgAN

Detailed description

Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.

Conditions

• Immunoglobulin A (IgA) Nephropathy

Interventions

Type	Name	Description
DRUG	Felzartamab	anti-CD38+ monoclonal antibody
OTHER	Placebo	Placebo comparator

Timeline

• Start date: 2021-08-31
• Primary completion: 2023-02-06
• Completion: 2024-05-06
• First posted: 2021-10-04
• Last updated: 2025-02-07

Locations

60 sites across 16 countries: United States, Australia, Belgium, Bulgaria, Czechia, Georgia, Germany, Japan, Malaysia, Philippines, Serbia, South Korea, Spain, Taiwan, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study