clinical trial · NCT04221477
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis
Lupus NephritisObinutuzumabMMFPrednisonePlaceboMethylprednisoloneAcetaminophenDiphenhydramine
brief 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.
started
Aug 10, 2020
primary completion
Aug 15, 2024
completion
Mar 2, 2031
last updated
Jul 21, 2026
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol