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.

Conditions

  • Lupus Nephritis

Intervention

  • Obinutuzumab
  • Placebo
  • Mycophenolate Mofetil
  • Acetaminophen/paracetamol
  • Diphenhydramine hydrochloride (HCl)
  • Methylprednisolone
  • Prednisone

Principal Investigator

  • De La Pena, Wendy

Sponsor

  • F. Hoffmann-La Roche, Ltd.

*The source of data for this particular study is "ClinicalTrials.gov" and was last updated on 05/16/2024. Loma Linda University does not make any warranties, expressed or implied, with respect to such data, and, furthermore, assumes no liability for any party's use, or the results of such use of the data.

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