Obinutuzumab - OBILUP
Obinutuzumab is a humanized, type II anti-CD20 monoclonal antibody that has a distinct mode of binding to the CD20 antigen compared with type I anti-CD20 antibodies and is glycoengineered for greater affinity for the FcγRIII on effector cells. These properties promote greater antibody-dependent cellular cytotoxicity, superior direct B-cell killing, and, thus, less reliance on complement-dependent cytotoxicity than type I anti-CD20 antibodies.
Enroll in this clinical study
How is Obinutuzumab being studied in Lupus nephritis?
This randomized, open-label, controlled non-inferiority phase III multicentre trial aimed to demonstrate that patients with lupus nephritis could be treated successfully without using damaging doses of oral corticosteroids.
Eligible patients will be randomized with a 1:1 ratio, between the interventional group (obinutuzumab, IV methylprednisolone, no or low dose corticosteroids, and MMF) and the control group (oral prednisone, IV methylprednisolone, and MMF)
The primary objective is to demonstrate that a regimen free of additional oral corticosteroids but with obinutuzumab (and MMF) is non-inferior to a regimen based on oral corticosteroids and MMF in achieving the primary outcome of complete renal response at week 52 without receiving corticosteroids above a prespecified dose.
Eligibility Criteria
Children aged 14-17 years old and adults
Active lupus nephritis, as defined by kidney biopsy within the preceding 8 weeks, assessed by the International Society of Nephrology/Renal Pathology Society (ISN/RPS) classification: class III or IV (A or A/C) ± V with active lesions in at least 10% of the viable glomeruli
Urine protein-to-creatinine ratio (uPCR) ≥ 0.5 g/g at any time in the 14 days before inclusion