85
Participants
Start Date
March 29, 2023
Primary Completion Date
September 4, 2025
Study Completion Date
September 4, 2026
Obinutuzumab
Obinutuzumab will be administered as per schedule specified in the respective arm.
MMF
MMF will be administered as per schedule specified in the respective arm.
Prednisone
Participants taking prednisone or equivalent at randomization will follow a guided tapering schedule to reach the goal of 0mg/day by Weeks 4-6 (and no later than Week 8 following randomization and continue without prednisone through Week 52.
Methylprednisolone
Methylprednisolone 80 mg (or 1.5 mg/kg if \</=45 kg) IV will be administered as premedication prior to infusions.
Acetaminophen/ Paracetamol
Acetaminophen 15 mg/kg (maximum dose 1000 mg) will be administered PO as premedication prior to infusions.
Diphenhydramine Hydrochloride
Diphenhydramine HCl 0.5-1 mg/kg (maximum dose 50 mg) will be administered PO or IV as premedication prior to infusions.
Hôpital Universitaire des Enfants Reine Fabiola, Brussels
UZ Gent, Ghent
Ospedale Infantile Regina Margherita - INCIPIT - PIN, Turin
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN, Genoa
Children's National Hospital, Washington D.C.
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico - Clinica De Marchi - INCIPIT - PIN, Milan
University of Virginia Health System, Charlottesville
Duke University Health Systems, Durham
Nemours Children's Hospital, Orlando
Memorial Healthcare System, Hollywood
University of South Florida, Tampa
CHU Montpellier- Hopital Arnaud de VIlleneuve, Montpellier
Hospital Universitario Marques de Valdecilla, Santander
Celal Bayar University Medical Faculty, Manisa
Hospital Universitario Cruces, Barakaldo
Chu Toulouse, Bron
Hopital Femme Mere Enfants, Bron
Hopital Necker - Enfants Malades, Paris
Hopital Robert Debre, Paris
Cedars Sinai Medical Center, Los Angeles
Hopital Henri Mondor, Créteil
Lucile Packard Children's Hospital - Stanford, Palo Alto
Peking University First Hospital, Beijing
The children's hospital , Zhejiang university school of medicine, Hangzhou
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech, Wuhan
Henan Children's Hospital Zhengzhou Children's Hospital, Zhengzhou
The First Affiliated Hospital of Sun Yat-sen University, Guangzhou
Xi'an Children's Hospital, Xi'an
Tokyo Metropolitan Children's Medical Center, Tokyo
Hyogo prefectural Kobe Children's Hospital, Hyogoken
University of California Benioff Children's Hospital, San Francisco
Nicklaus Children's Hospital, Miami
Children's Healthcare of Atlanta Center for Advanced Pediatrics, Atlanta
University of Michigan, Ann Arbor
Hackensack University Medical Center, Hackensack
UNC Hospitals Outpatient Center at Eastowne, Chapel Hill
Levine Children's Hospital, Charlotte
University of Utah - Primary Children's Hospital - PPDS, Salt Lake City
Instituto Méderi de Pesquisa e Saúde, Passo Fundo
Irmandade Da Santa Casa de Misericordia de Porto Alegre, Porto Alegre
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS, São José do Rio Preto
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, São Paulo
CHU de Nice, Nice
Hokkaido University Hospital, Hokkaido
Kobe University Hospital, Hyōgo
Yokohama City University Medical Center, Kanagawa
Kitasato University Hospital, Kanagawa
Dokkyo Medical University Hospital, Mibu-Machi
Shiga University Of Medical Science Hospital, Shiga
National Center for Child Health and Development, Tokyo
Uniwersytecki Szpital Kliniczny w Bialymstoku, Bia?ystok
In-VIVO Osrodek Badan Klinicznych, Bydgoszcz
Uniwersyteckie Centrum Kliniczne, Gdansk
Dzieciecy Szpital Kliniczny UCK WUM, Warsaw
Hospital Sant Joan de Deu - PIN, Barcelona
Hoffmann-La Roche
INDUSTRY