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

Launched by HOFFMANN-LA ROCHE · Sep 1, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medication called obinutuzumab to see how well it works and how safe it is for adolescents aged 12 to less than 18 years who have a condition called lupus nephritis, which affects the kidneys. The study also aims to gather safety information about the medication for younger children aged 5 to less than 12 years with the same condition. Participants will either receive obinutuzumab or a placebo (a treatment that looks the same but has no active medicine) to compare the effects.

To be eligible for this trial, adolescents must have a confirmed diagnosis of active lupus nephritis and have experienced significant kidney problems, as shown by specific tests. They should not have any severe complications or other serious health issues that could interfere with the study. Participants can expect to be closely monitored during the trial, and their health will be regularly checked to ensure their safety. This study is currently recruiting participants, and it's an important step in finding better treatments for lupus nephritis in children and adolescents.

Gender

ALL

Eligibility 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