A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis

Phase 3 Active, not recruiting NCT04221477

Condition	Lupus Nephritis
Phase	Phase 3
Sponsor	Hoffmann-La Roche
Status	Active, not recruiting
Enrollment	271 participants
Interventions	Obinutuzumab, MMF, Prednisone, Methylprednisolone, Acetaminophen
Start date	Aug 10, 2020
Completion date	Aug 15, 2024
Results posted	Nov 6, 2025

Summary

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.

Percentage of Participants With Complete Renal Response (CRR)

At Week 76 · percentage of participants

Obinutuzumab	46.4 percentage of participants
Placebo	33.1 percentage of participants

p-value	0.0232
Adjusted Difference	13.40 (95% CI 1.95–24.84)

Open in BENITIONS View on ClinicalTrials.gov

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