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Looking for participantsPhase2

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

NCT ID: NCT05039619

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Obinutuzumab (drug), Placebo (drug), Mycophenolate Mofetil (drug), Acetaminophen/paracetamol (drug)
How long the study runs
Study runs about 97 months (dates as stated)
About the drug or intervention
Obinutuzumab — drug: 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 — drug: Placebo matching obinutuzumab will be administered by IV on Day 1, Day 14, Week 24, Week 26 and Week 52. · Mycophenolate Mofetil — drug: 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 — drug: Acetaminophen 1000 mg will be administered as pre-medication prior to infusions. · Diphenhydramine hydrochloride (HCl) — drug: Diphenhydramine HCl 50 mg will be administered as pre-medication prior to infusions. · Methylprednisolone — drug: Methylprednisolone 80 mg IV will be administered as pre-medication prior to infusions. · Prednisone — drug: 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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
5 Years to 17 Years
Who
All
Number of participants
40
Started
2022-05-12
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for lupus nephritis
  • • Phase2 - 40 participants
  • • 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)

Who can take part?

  • • Ages 5 Years to 17 Years
  • • Diagnosed with lupus nephritis

Where?

  • • Glasgow - Royal Hospital For Children
  • • Liverpool - Alder Hey Childrens Hospital
  • • London - Great Ormond Street Hospital for Children

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Lupus Nephritis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 5 Years - 17 Years
  • Who can join: All genders

What the study is looking for

  • ✓Participants who are age 12 to \<18 years at the time of randomization
  • ✓International Society of Nephrology and the kidney Pathology Society (ISN/RPS) 2003 Class III or IV active LN...
  • ✓Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are...
  • ✓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

Who cannot take part

  • ✗Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute...
  • ✗Sclerosis in \>50% of glomeruli on kidney biopsy
  • ✗Purely chronic Class III(c) or Class IV(c) disease on kidney biopsy, defined as the absence of any active lesions
  • ✗Presence of rapidly progressive glomerulonephritis
  • ✗Pure Class V LN
See the full criteria
Inclusion Criteria: * 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 Criteria: * 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

Where Is This Study? (3 UK sites)

Royal Hospital For Children

Glasgow G51 4TF, United Kingdom

WITHDRAWN

Alder Hey Childrens Hospital

Liverpool L12 2AP, United Kingdom

Recruiting
Hospital R&D contact (matched)

Kelly Davies

research@alderhey.nhs.uk0151 2525570

Great Ormond Street Hospital for Children

London WC1N 3JH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: Research.Governance@gosh.nhs.uk

Research.Governance@gosh.nhs.uk0207 905 2700

How to Get in Touch

Reference Study ID Number: WA42985 https://forpatients.roche.com/ No attachments to email below.

Sponsor contact

CONTACT

888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-10