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Obinutuzumab for Lupus Nephritis in Adolescents and Children

This study is testing a drug called obinutuzumab in young people with lupus nephritis (lupus affecting the kidneys). It aims to see how safe and effective obinutuzumab is, and how the body handles the drug. Participants will receive obinutuzumab or a placebo (an inactive substance) through an IV, along with mycophenolate mofetil (an oral medication). Pre-medications like acetaminophen and diphenhydramine will be given before infusions. The study is looking for how many participants achieve a complete kidney response and any side effects. It includes adolescents aged 12 to under 18, and will later include children aged 5 to under 12. The study is currently recruiting adolescents, with recruitment for younger children to follow.

Study design
This is a Phase II, randomized, double-blind, placebo-controlled study involving up to 40 participants. It will compare obinutuzumab to a placebo in adolescents, and also look at obinutuzumab in an open-label way for younger children.
What's involved
Participants will receive IV infusions of obinutuzumab or placebo on specific days over about a year. They will also take mycophenolate mofetil orally at home daily.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and kidney response from baseline up to Week 76 (about 1.5 years).

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NCT05039619

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

Recruiting
PHASE2Ages 5–17InterventionalTreatment
Hoffmann-La Roche
~40 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:ObinutuzumabPlaceboMycophenolate MofetilAcetaminophen/paracetamolDiphenhydramine hydrochloride (HCl)Methylprednisolone

At a glance

Recruiting sites
33 of 43 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants who Achieve a Complete Renal Response (CRR) (AP)
Measured over Week 76
+1 more outcome measured

Conditions

Lupus Nephritis

Explore related trials

Lupus Glomerulonephritis

Where it's being run

43 sites across 30 states
France4
South Africa3
Spain3
United Kingdom3
California2
São Paulo2
Peru2
Poland2

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: WA42985 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728 (U.S. and Canada)
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Eligibility criteria

Inclusion

Participants who are age 12 to \<18 years at the time of randomization
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

Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia
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

What this trial measures

  • Percentage of Participants who Achieve a Complete Renal Response (CRR) (AP)Week 76

    CRR is defined as achievement of all of the following: * Urinary protein-to-creatinine ratio (UPCR) \<0.5 g/g * Estimated Glomerular Filtration Rate (eGFR) \>=85% of baseline * No occurrence of intercurrent events

  • Percentage of Participants with Adverse Events (PP)Baseline to Week 76