Phase II Study of Obinutuzumab for Safety and Effectiveness in Children and Teens with Active Lupus Nephritis

What this Trial Is About

Researchers are evaluating obinutuzumab in adolescents aged 12 to less than 18 years with biopsy-confirmed proliferative lupus nephritis LN in this phase II, randomized, double-blind, placebo-controlled study. The trial also examines the open-label safety and pharmacokinetics of obinutuzumab in younger pediatric participants aged 5 to less than 12 years with LN. The study aims to assess the treatments safety, effectiveness, and behavior in the body. Participants aged 12 to less than 18 will be randomly assigned to receive either obinutuzumab or a placebo by intravenous infusion at specific times Day 1, Day 14, Week 24, Week 26, and Week 52. Dosage depends on body weight, with those weighing 45 kg or more receiving 1000 mg, and lighter participants getting a weight-adjusted dose. Younger children aged 5 to less than 12 will receive open-label obinutuzumab infusions on the same schedule. Additional medications like mycophenolate mofetil, acetaminophen, diphenhydramine, methylprednisolone, and prednisone are used as part of the treatment regimen. Participants will be closely monitored over 76 weeks with evaluations including kidney response, adverse events, blood tests, and quality of life assessments. Researchers will track changes in proteinuria, kidney function, immune markers, and fatigue levels. Safety will be assessed by recording side effects and antibody development. The study includes frequent visits for infusions and assessments, with ongoing follow-up to measure treatment response and safety over time.

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