This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to \<12 with LN.
Participants who are age 12 to <18 years at the time of randomization
Participants who are age 5 to <12 years (younger participant cohort) at the time of randomization once recruitment is open. (Investigators will be notified by the Sponsor when recruitment is open to this younger population)
International Society of Nephrology and the Renal Pathology Society (ISN/RPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed in the 12 months prior to or during screening
Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible
Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia
Sclerosis in >50% of glomeruli on renal biopsy
Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions
Presence of rapidly progressive glomerulonephritis
Hoffmann-La Roche
Lead sponsor
Genentech, Inc.
Collaborator