Research Project
Project Title: |
A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF OBINUTUZUMAB IN ADOLESCENT PATIENTS WITH ACTIVE CLASS III OR IV LUPUS NEPHRITIS, INCLUDING AN EVALUATION OF OPEN LABEL SA |
Project Type: |
Clinical Trial, Enrolment ongoing Adjunct biobank: Serum, Plasma |
Disease group(s): |
Immune glomerulopathies |
Project Summary: |
The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of obinutuzumab in adolescent participants (12 to  18 years old) with International Society of Nephrology and the Renal Pathology Society (ISN/RPS) Class III or IV active lupus nephritis (proliferative LN) receiving standard of care therapy with mycophenolate mofetil (MMF) and corticosteroids. A younger age cohort (5 to  12 years old) with ISN/RPS Class III or IV active lupus nephritis receiving standard of care therapy with MMF and corticosteroids may also be enrolled in this study upon confirmation of the pharmacokinetic (PK) exposureand dose selection in this age group (see Section 4.1). Safety and pharmacokinetics of obinutuzumab in this younger age cohort will be evaluated via enrollment of participants aged 5 to  12 in an open-label arm of this study. |
Lead principal investigator(s): |
Giovanni Montini, Milan |
Co-investigator(s): |
Antonio Mastrangelo, Milan |
Project Period: |
11/2022 - 11/2050 |
Sponsors: |
Industry |
Project web page: |
https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2023-505825-15-00 |
EudraCT Nr.: |
2021-000097-29 |
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