Tests obinutuzumab in young people with lupus kidney disease
Tests obinutuzumab against placebo in adolescents with active lupus nephritis.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Cape Town and Panorama, South AfricaSee the 3 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 5 and 17 years old?
Source: NCT05039619, who can take part
Where in South Africa
- Groote Schuur HospitalCape Town, South AfricaNo longer taking part
- Red Cross War Memorial Children?s HospitalCape Town, South AfricaNo longer taking part
- Panaroma Medical CenterPanorama, South AfricaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT05039619EU 2023-505825-15-00
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients With Active Class III or IV Lupus Nephritis, Including an Evaluation of Open Label Safety and PK in a Cohort of Pediatric Patients (Aged 5 to < 12)
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.
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: 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; Significant or uncontrolled concomitant medical disease which, in the investigator's opinion, would preclude participant participation; Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia; Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions; 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; Currently active alcohol or drug abuse or history of alcohol or drug abuse; Sclerosis in >50% of glomeruli on renal biopsy; Presence of rapidly progressive glomerulonephritis; Pure Class V LN.