Clinical Research Studies

This is a parallel-group, double-blind, randomized, placebo-controlled study comparing the efficacy and safety of obinutuzumab versus placebo among patients with ISN/RPS 2003 Class III or IV LN treated with standard-of-care therapy with MMF and corticosteroids. The study will enroll approximately 252 patients. Patients must be 18?75 years of age and have ISN/RPS Class III or IV proliferative LN as evidenced by renal biopsy performed in the 6 months prior to screening or during screening. Patients may have concomitant Class V disease (i.e., Class III/V or Class IV/V). Patients must exhibit significant proteinuria as evidenced by a UPCR ? 1 based on a 24-hour urine collection during screening. Key exclusion criteria include evidence of severe renal impairment, defined by an eGFR ? 30 mL/min per 1.73 m2 of body surface area or ESRD requiring dialysis or transplantation; evidence of active infection; and other safety-related exclusions. The study consists of the following study periods: screening, blinded treatment, open-label treatment (OLT), and study follow-up.