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
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CONTACT
Lead
Hoffmann-La Roche
With
Genentech, Inc.
Age
5–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
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
Clareo Health | 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
