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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
Where Is This Study? (3 UK sites)
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
Main Email: Research.Governance@gosh.nhs.uk
Research.Governance@gosh.nhs.uk0207 905 2700How to Get in Touch
Reference Study ID Number: WA42985 https://forpatients.roche.com/ No attachments to email below.
Sponsor contactCONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Sponsor contactCONTACT
