Safety Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis.

  • STATUS
    Recruiting
  • End date
    Sep 22, 2022
  • participants needed
    75
  • sponsor
    Novartis Pharmaceuticals
Updated on 22 April 2021
body mass index
corticosteroids
methotrexate
immunosuppressive agents
hydroxychloroquine
histological diagnosis
azathioprine
proteinuria
mycophenolate
antinuclear antibody
hematuria
systemic lupus erythematosus
nephritis

Summary

This study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic efficacy of multiple doses of CFZ533 anti-CD40 monoclonal antibody in patients with moderately active lupus nephritis.

Description

This is a randomized, subject and investigator blind, placebo controlled multicenter study with multiple doses of CFZ533 administered by 1-hour intravenous infusion over a 24 week treatment period, as compared to matched placebo infusion. The treatment period will be followed by a 24-week safety follow-up period.The duration of the study (including the screening period) for each patient will be approximately 53 weeks. The investigational drug or placebo will be administered on top of standard of care therapy for lupus nephritis.

Patients will be screened within 29 days of the first study drug infusion. Eligibility will be confirmed at the baseline visit within one week before the first dose. Eligible patients will be assigned a randomization number and receive the intravenous infusion within 3 days of baseline visit.

Details
Condition Glomerulonephritis, SYSTEMIC LUPUS ERYTHEMATOSUS, Lupus Nephritis
Treatment Placebo, CFZ533
Clinical Study IdentifierNCT03610516
SponsorNovartis Pharmaceuticals
Last Modified on22 April 2021

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