ISN/RPS 2003 Class III or IV lupus nephritis (LN) Digestive System
Conditions
Interventions
Randomization will be carried out using the interactive web response system (IxRS).
Obinutuzumab Arm 1:
Participants will receive blinded obinutuzumab, 1000 milligrams (mg), intravenously (IV), at ba
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants with the diagnosis of active or active/chronic ISN/RPS 2003 Class III or IV proliferative LN by renal biopsy performed in the 6 months prior to screening or during screening. 2. Participants with the diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria, which are met by the presence of Class III or IV LN and current or past positive antinuclear antibody (ANA). 3. Participants who have urinary protein to creatinine ratio (UPCR) =1 gram per gram (g/g) on a 24-hour collection at screening. 4. Receipt of at least one dose of pulse IV methylprednisolone (=250 mg) or equivalent for treatment of the current episode of active LN during the 6 months prior to screening or during screening or on Day 1 prior to the first infusion.
Exclusion criteria
Exclusion criteria: 1. Participants who have severe renal impairment, as defined by estimated glomerular filtration rate (eGFR) 50% of on renal biopsy 3. Participants who have rapidly progressive glomerulonephritis 4. Participants with severe, active central nervous system SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia 5. Participants who have a history of progressive multifocal leukoencephalopathy (PML) 6. Participants who have human immunodeficiency virus (HIV) infection 7. Participants who have tuberculosis (TB) infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with complete renal response (CRR) calculated programmatically based on central laboratory test results and investigator assessments at Week 76 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants with proteinuric response calculated programmatically based on samples from 24-hour urine collection at Week 76 2. Percentage of participants with CRR with successful prednisone taper calculated programmatically based on central laboratory test results and investigator assessments at Week 76 3. Percentage of participants with overall renal response (ORR) calculated programmatically based on central laboratory test results and investigator assessments at Week 50 4. Percentage of participants who died or experienced renal-related events calculated programmatically based on central laboratory test results and investigator assessments from baseline up to Week 76 5. Mean change in eGFR estimated using the chronic kidney disease epidemiology collaboration (CKD-EPI) equation from baseline to Week 76 6. Change in anti-double-stranded deoxyribonucleic acid (anti-dsDNA) level determined using blood samples collected from baseline to Week 50 7. Change in complement 3 (C3) levels determined using blood samples collected from baseline up to Week 50 8. Change in systemic lupus erythematosus (SLE) disease assessed using systemic lupus erythematosus disease activity index 2000 (SLEDAI 2K) from baseline up to Week 76 9. Time to onset of CRR determined programmatically based on central laboratory test results and investigator assessments from baseline up to 76 weeks 10. Change in functional assessment of chronic illness therapy-fatigue (FACIT-F) scale used to assess treatment benefit of obinutuzumab in participants with SLE from baseline to Week 76 11. Percentage of participants with CRR according to serum creatinine criteria calculated programmatically based on central laboratory test results and investigators' assessment at Week 76 | — |
Countries
China
Contacts
Public ContactClinical Trials
Outcome results
None listed