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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
Sponsor: Hoffmann-La Roche
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.
Official 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 Safety and PK in a Cohort of Pediatric Patients (Aged 5 to < 12)
Key Details
Gender
All
Age Range
5 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2022-05-12
Completion Date
2030-06-14
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
Obinutuzumab
Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1, Day 14, Week 24, Week 26 and Week 52.
Placebo
Placebo matching obinutuzumab will be administered by IV on Day 1, Day 14, Week 24, Week 26 and Week 52.
Mycophenolate Mofetil
Mycophenolate Mofetil (MMF) will be taken by home administration orally at a target dose of 1200 mg/m\^2/day to a maximum of 2.5g/day from baseline (Day 1) onwards.
Acetaminophen/paracetamol
Acetaminophen 1000 mg will be administered as pre-medication prior to infusions.
Diphenhydramine hydrochloride (HCl)
Diphenhydramine HCl 50 mg will be administered as pre-medication prior to infusions.
Methylprednisolone
Methylprednisolone 80 mg IV will be administered as pre-medication prior to infusions.
Prednisone
Oral prednisone or equivalent corticosteroid will be taken by home administration daily to a maximum dose of 60mg/day followed by a guided taper to 5mg/day or less by Week 24.
Locations (42)
Loma Linda University health
Loma Linda, California, United States
UCSF Benioff Childrens Hospital
San Francisco, California, United States
Children's Hospital Colorado, Anchutz Medical Campus
Aurora, Colorado, United States
Emory Children's Center
Atlanta, Georgia, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
Louisiana State University
Shreveport, Louisiana, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Cohen Children's Medical Center of New York
Queens, New York, United States
Cincinnati Childrens Hospital
Cincinnati, Ohio, United States
Chldren?s Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Texas Arthritis Center
El Paso, Texas, United States
Ser Servicos Especializados Em Reumatologia
Salvador, Estado de Bahia, Brazil
Centro de Pesquisa São Lucas
Campinas, São Paulo, Brazil
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, Brazil
Universidade Federal de Sao Paulo - UNIFES
São Paulo, Brazil
The Hospital for Sick Children
Toronto, Ontario, Canada
Hospital Sainte-Justine
Montreal, Quebec, Canada
CH de Bicêtre
Le Kremlin-Bicêtre, France
Hôpital Robert Debré
Paris, France
Hop Necker Enfants Malades
Paris, France
CHU de Toulouse - Hôpital des Enfants
Toulouse, France
Ospedale Pediatrico Bambino Gesu
Rome, Lazio, Italy
IRCCS G. Gaslini
Genoa, Liguria, Italy
Clinica Pediatrica II De Marchi
Milan, Lombardy, Italy
CREA Hospital Mexico Americano
Guadalajara, Jalisco, Mexico
Clinstile S.A de C.V.
Mexico City, Mexico CITY (federal District), Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico
Instituto de Ginecología y Reproducción
Lima, Peru
Clinica El Golf
San Isidro, Peru
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Szpital Specjalistyczny dla Dzieci i Doroslych
Torun, Poland
Saint-Petersburg State
St-peterburg, Sankt-Peterburg, Russia
Red Cross War Memorial Children?s Hospital
Cape Town, South Africa
Groote Schuur Hospital
Cape Town, South Africa
Panaroma Medical Center
Panorama, South Africa
Hospital Sant Joan De Deu
Esplugas de Llobregat, Barcelona, Spain
Hospital Ramon y Cajal
Madrid, Spain
Hospital de La Paz
Madrid, Spain
Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica
Valencia, Spain
Royal Hospital For Children
Glasgow, United Kingdom
Alder Hey Childrens Hospital
Liverpool, United Kingdom
Great Ormond Street Hospital for Children
London, United Kingdom