A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis
Trial ID or NCT#
NCT04221477
Status
NOT RECRUITING
Purpose
This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in participants with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.
Official Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis
Eligibility Criteria
Ages Eligible for Study: 18 to 75
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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 participant participation* Known active infection of any kind or recent major episode of infection* Intolerance or contraindication to study therapies* Other exclusion criteria may apply
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 participant participation* Known active infection of any kind or recent major episode of infection* Intolerance or contraindication to study therapies* Other exclusion criteria may apply
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Elizabeth Chen
(650) 721-3848
View on ClinicalTrials.gov
