Randomized, placebo-controlled, multi-center, double-blind, proof of concept phase IIa trial and dose evaluation trial of felzartamab in IgAN
Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
anti-CD38+ monoclonal antibody
Placebo comparator
Efficacy: Relative change in Proteinuria value
Time frame: 9 months compared to baseline
Safety: determined by the frequency, incidence and severity of TEAEs
Time frame: Ongoing through study completion, up to 2 years
Efficacy: Relative change in proteinuria value
Time frame: Ongoing through treatment completion, an average every 3 months per treatment period, up to 2 years
Efficacy: complete response in patients with IgAN
Time frame: Ongoing through treatment completion, an average every 3 months per treatment period, up to 2 years
Pharmacokinetic: serum concentrations of Felzartamab over time
Time frame: Ongoing through treatment completion, up to 2 years
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