Last updated 19 days ago
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
40 patients around the world
Available in United States, Brazil, Peru, Spain
Hoffmann-La Roche
3Research sites
40Patients around the world
This study is for people with
Lupus
Lupus nephritis
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- Participants who are age 12 to <18 years at the time of randomizationParticipants 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 screeningClass V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligibleDiagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteriaSignificant proteinuria defined by a UPCR above > 0.5 based on a first-morning void (FMV) collection at screeningDuring 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 dementiaSclerosis in >50% of glomeruli on renal biopsyPurely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesionsPresence of rapidly progressive glomerulonephritisPure Class V LNIntolerance or contraindication to study therapiesActive 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 randomizationHistory of or currently active primary or secondary immunodeficiency, including known history of HIV infection and other severe Immunodeficiency blood disordersHistory of serious recurrent or chronic infectionHistory 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 yearsSignificant or uncontrolled concomitant medical disease which, in the investigator's opinion, would preclude participant participationCurrently active alcohol or drug abuse or history of alcohol or drug abuse
Sites
SER - Serviços Especializados em Reumatologia da Bahia
Recruiting
Hospital das Clínicas da Faculdade de Medicina da São Paulo - USP
Recruiting
Hospital Universitario Dr. José Eleuterio González
Recruiting
StudyPOSTERITY
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Lupus nephritis
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05039619
