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
NCT ID: NCT05039619
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2022-05-12
2029-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Blinded Obinutuzumab
Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusions on Day 1, Day 14, Week 24, Week 26 and Week 52. Participants with a body weight of 45 kg or more will receive the 1000 mg dose. Participants with a body weight below 45 kg will receive a weight adjusted dose of 20 mg/kilogram (kg).
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.
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.
Placebo
Placebo participants will receive obinutuzumab matched placebo 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.
Open-Label Obinutuzumab
Younger participants aged 5 to \<12 will receive obinutuzumab 1000 mg IV infusions on Days 1, 14, Week 24, Week 26 and Week 52.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants who are age 5 to \<12 years (younger participant cohort) at the time of randomization once recruitment is open. (Investigators will be notified by the Sponsor when recruitment is open to this younger population)
* International Society of Nephrology and the Renal Pathology Society (ISN/RPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed in the 12 months prior to or during screening
* Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible
* Diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria
* Significant proteinuria defined by a UPCR above \> 0.5 based on a first-morning void (FMV) collection at screening
* During the 12 months prior to or during screening, all participants must have received at least one dose of pulse-range IV methylprednisolone (typically 30 mg/kg, maximum of 1000 mg per dose) or equivalent for the treatment of the current episode of active LN.
Exclusion Criteria
* Sclerosis in \>50% of glomeruli on renal biopsy
* Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions
* Presence of rapidly progressive glomerulonephritis
* Pure Class V LN
* Intolerance or contraindication to study therapies
* Active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV anti-infective medications within 4 weeks prior to screening, or completion of oral anti-infectives within 2 weeks prior to randomization
* History of or currently active primary or secondary immunodeficiency, including known history of HIV infection and other severe Immunodeficiency blood disorders
* History of serious recurrent or chronic infection
* History of or current cancer, including solid tumors, hematological malignancies, and carcinoma in situ (except basal cell carcinoma and squamous cell carcinoma of the skin that have been excised and cured) within the past 5 years
* Significant or uncontrolled concomitant medical disease which, in the investigator's opinion, would preclude participant participation
* Currently active alcohol or drug abuse or history of alcohol or drug abuse
5 Years
17 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Countries
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Central Contacts
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Reference Study ID Number: WA42985 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S. and Canada)
Email: [email protected]
References
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Dossier C, Bonneric S, Baudouin V, Kwon T, Prim B, Cambier A, Couderc A, Moreau C, Deschenes G, Hogan J. Obinutuzumab in Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome in Children. Clin J Am Soc Nephrol. 2023 Dec 1;18(12):1555-1562. doi: 10.2215/CJN.0000000000000288. Epub 2023 Sep 6.
Other Identifiers
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2021-000097-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-505825-15-00
Identifier Type: OTHER
Identifier Source: secondary_id
WA42985
Identifier Type: -
Identifier Source: org_study_id