A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis

• Status: Recruiting
• Trial end date: 2028-04-18
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Acetaminophen; Diphenhydramine; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Mycophenolic Acid; Obinutuzumab; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone; Promethazine

Criteria

Key Inclusion Criteria:

• Diagnosis of active or active/chronic ISN/RPS 2003 Class III or IV proliferative LN as evidenced by renal biopsy performed within 6 months. Participants may co-exhibit Class V disease in addition to either Class III or Class IV disease

• Urine protein to creatinine ratio greater than or equal to (>/=) 1 on a 24-hour collection

• Other inclusion criteria may apply

Key Exclusion Criteria:

• Pregnancy or breastfeeding

• Severe renal impairment or the need for dialysis or renal transplantation

• Receipt of an excluded therapy, including any anti-CD20 therapy less than 9 months prior to screening or during screening; or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening

• Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation

• Known active infection of any kind or recent major episode of infection

• Intolerance or contraindication to study therapies

• Other exclusion criteria may apply