Last updated on July 2019

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


Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT03610516

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