Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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
Funding Agency/Sponsor
Industry
Disease
Lupus
Enrollment Eligibility
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