A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
Start Date
5/12/2022
Completion Date
6/14/2030
Summary
This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to \<12 with LN.
Eligibility Criteria
Age Range: 5 years to 17 years
Interventions
Obinutuzumab
Placebo
Mycophenolate Mofetil
Acetaminophen/paracetamol
Diphenhydramine hydrochloride (HCl)
Methylprednisolone
Prednisone
Conditions
Locations
Loma Linda University health
Loma Linda, California 92354
United States
UCSF Benioff Childrens Hospital
San Francisco, California 94158
United States
Children's Hospital Colorado, Anchutz Medical Campus
Aurora, Colorado 80045
United States
Emory Children's Center
Atlanta, Georgia 30322
United States
Indiana University Health University Hospital
Indianapolis, Indiana 46202
United States
Louisiana State University
Shreveport, Louisiana 71103
United States
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Cohen Children's Medical Center of New York
Queens, New York 11042
United States
Cincinnati Childrens Hospital
Cincinnati, Ohio 45229
United States
Chldren?s Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
Texas Arthritis Center
El Paso, Texas 79902
United States
Ser Servicos Especializados Em Reumatologia
Salvador, Estado de Bahia 40150-150
Brazil
Centro de Pesquisa São Lucas
Campinas, São Paulo 13060-904
Brazil
Hospital das Clinicas - FMUSP
São Paulo, São Paulo 05403-000
Brazil
Universidade Federal de Sao Paulo - UNIFES
São Paulo, 04024-002
Brazil
The Hospital for Sick Children
Toronto, Ontario M5G 1X8
Canada
Hospital Sainte-Justine
Montreal, Quebec H3T 1C5
Canada
CH de Bicêtre
Le Kremlin-Bicêtre, 94275
France
Hôpital Robert Debré
Paris, 75019
France
Hop Necker Enfants Malades
Paris, 75743
France
CHU de Toulouse - Hôpital des Enfants
Toulouse, 31000
France
Ospedale Pediatrico Bambino Gesu
Rome, Lazio 00165
Italy
IRCCS G. Gaslini
Genoa, Liguria 16148
Italy
Clinica Pediatrica II De Marchi
Milan, Lombardy 20122
Italy
CREA Hospital Mexico Americano
Guadalajara, Jalisco 44620
Mexico
Clinstile S.A de C.V.
Mexico City, Mexico CITY (federal District) 06700
Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León 64460
Mexico
Instituto de Ginecología y Reproducción
Lima,
Peru
Clinica El Golf
San Isidro, L27 Lima
Peru
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-294
Poland
Szpital Specjalistyczny dla Dzieci i Doroslych
Torun, 87-100
Poland
Saint-Petersburg State
St-peterburg, Sankt-Peterburg 194100
Russia
Red Cross War Memorial Children?s Hospital
Cape Town, 7700
South Africa
Groote Schuur Hospital
Cape Town, 7925
South Africa
Panaroma Medical Center
Panorama, 7500
South Africa
Hospital Sant Joan De Deu
Esplugas de Llobregat, Barcelona 08950
Spain
Hospital Ramon y Cajal
Madrid, 28034
Spain
Hospital de La Paz
Madrid, 28046
Spain
Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica
Valencia, 46026
Spain
Royal Hospital For Children
Glasgow, G51 4TF
United Kingdom
Alder Hey Childrens Hospital
Liverpool, L12 2AP
United Kingdom
Great Ormond Street Hospital for Children
London, WC1N 3JH
United Kingdom