Project 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 EUDRACT |
Project Type: |
Clinical Trial, Enrolment terminated |
Disease group(s): |
Immune glomerulopathies |
Project 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. |
Lead principal investigator(s): |
Loreto Gesualdo, Bari |
Co-investigator(s): |
Adele Mitrotti, Bari F Bagagli, Bari |
Project Period: |
06/2022 - 02/2028 |
Sponsors: |
Industry |
ClinicalTrials.gov: |
NCT04221477 |