Research Project

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

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