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

  • End date
    Dec 29, 2022
  • participants needed
  • sponsor
    Novartis Pharmaceuticals
Updated on 31 July 2021
body mass index
immunosuppressive agents
histological diagnosis
antinuclear antibody
systemic lupus erythematosus


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.


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.

Condition Glomerulonephritis, SYSTEMIC LUPUS ERYTHEMATOSUS, Lupus Nephritis
Treatment Placebo, CFZ533
Clinical Study IdentifierNCT03610516
SponsorNovartis Pharmaceuticals
Last Modified on31 July 2021


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