BENITIONSClinical Trial Intelligence

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

Phase 2 Completed NCT05065970

ConditionImmunoglobulin A Nephropathy
PhasePhase 2
SponsorHI-Bio, A Biogen Company
StatusCompleted
Enrollment54 participants
InterventionsFelzartamab
Start dateAug 31, 2021
Completion dateFeb 6, 2023
Results postedApr 28, 2026

Summary

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

Part 1: Relative Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) in 24-hour Urine at Month 9

Baseline, Month 9 · gram per gram (g/g)

Part 1: Placebo-24.7 ± 19.43 gram per gram (g/g)
Part 1: Felzartamab Dosing Arm M1-16.5 ± 19.41 gram per gram (g/g)
Part 1: Felzartamab Dosing Arm M2-30.6 ± 21.72 gram per gram (g/g)
Part 1: Felzartamab Dosing Arm M3-38.5 ± 16.60 gram per gram (g/g)
p-value0.6837
Geometric LS Mean Ratio1.11 (95% CI 0.67–1.84)

Open in BENITIONS View on ClinicalTrials.gov

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