← Klinické štúdie • Glomerulopatie
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
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)
Stručný súhrn
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.
Základné údaje
| Ochorenia | Lupus Nephritis |
|---|---|
| Intervencie |
DRUG: Obinutuzumab DRUG: Placebo DRUG: Mycophenolate Mofetil DRUG: Acetaminophen/paracetamol DRUG: Diphenhydramine hydrochloride (HCl) DRUG: Methylprednisolone DRUG: Prednisone |
| Sponzor | Hoffmann-La Roche |
| Plánovaný počet | 40 |
| Začiatok | 2022-05-12 |
| Predp. ukončenie (primárne) | 2028-06-15 |
| Krajiny | United States, Brazil, Canada, France, Italy, Mexico, Peru, Poland, Russia, South Africa, Spain, United Kingdom |
| Posledná aktualizácia | 2026-06-03 |