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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 Patients (Aged 5 To < 12) (POSTERITY)
EU CTIS ID: 2023-505825-15-00
What this study is testing
To evaluate the efficacy of obinutuzumab compared with placebo in adolescent participants (AP) with Class III/IV LN To evaluate the safety of obinutuzumab and characterize the obinutuzumab PK profile in pediatric patients (PP) aged 5 to <12 with LN
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adolescents ages 12 to <18 at the time of randomisation; younger cohort age 5 to < 12 at time of randomisation
- International Society of Nephrology/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
- Positive current or historical test for antinuclear antibody (ANA) and/or antibodies to double-stranded DNA (dsDNA)
- Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible
- Significant proteinuria defined by a urine protein-to-creatinine ratio (UPCR) above >0.5 g/g 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
You likely can't join if
- Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia
- Severe renal impairment, as indicated by glomerular filtration rate (GFR) within the past 6 months <30 mL/min/1.73m^2 estimated using the modified Bedside Schwartz equation or as indicated by the need for renal transplant, plasmapheresis or dialysis at screening
- Sclerosis in >50% of glomeruli on renal biopsy and purely chronic Class III(c) or Class IV(c) disease on renal biopsy
- 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 current cancer, including solid tumors, hematological malignancies, and carcinoma in situ within the past 5 years
- Significant or uncontrolled concomitant medical disease which, in the investigator’s opinion, would preclude participant participation
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Peru
- Mexico
- United Kingdom
- United States
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Peru; Mexico; United Kingdom; United States; Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.