Kezar Life Sciences is evaluating zetomipzomib (KZR-616) in the Phase 2b PALIZADE clinical trial as a potential new treatment for individuals with active lupus nephritis. This randomized, double-blind, placebo-controlled, multicenter study aims to assess the efficacy and safety of zetomipzomib in patients suffering from this severe complication of systemic lupus erythematosus (SLE).
PALIZADE Trial Design
The PALIZADE trial is designed to evaluate two different doses of zetomipzomib (30 mg and 60 mg) against a placebo. Participants will receive weekly subcutaneous injections of either zetomipzomib or placebo over a 52-week treatment period. The study includes a screening phase to determine eligibility, the treatment phase, and a follow-up visit four weeks after treatment completion to monitor safety and side effects.
Patients participating in the trial have a 2 in 3 chance of receiving zetomipzomib. Throughout the trial, patients can continue taking other medications prescribed by their physicians for managing their lupus nephritis.
Inclusion and Exclusion Criteria
To be eligible for the PALIZADE study, participants must be at least 18 years of age and have a confirmed diagnosis of active lupus nephritis (Class III or IV, with or without Class V, or Class V alone) based on a kidney biopsy completed within the past year. Specific inclusion criteria also require a urine protein to creatinine ratio (UPCR) ≥1.0 for Class III/IV +/-V or UPCR ≥2.0 for Class V, a body mass index (BMI) ≥18 kg/m2, and positive results from an ANA test and/or an anti-dsDNA serum antibody test. Adequate blood cell counts, liver, and kidney function, based on lab results, are also necessary.
Exclusion criteria include a history of central nervous system manifestations of SLE, overlapping autoimmune conditions, antiphospholipid syndrome with a history of thromboembolic events within the 52 weeks prior to screening, thrombocytopenia, a history of solid organ transplant, active cancer, a positive test for HIV or hepatitis B/C, or known intolerance to mycophenolate mofetil or corticosteroids.
Study Logistics and Support
The PALIZADE clinical trial is being conducted globally, including in the United States and 20 other countries. Accommodations for study participation, such as clinical trial assessments at no cost, remote home trial services, and travel concierge services, may be available, varying by clinical trial location.
