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)

Summary

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.

Eligibility

Age range

5–17 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Obinutuzumab

  Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1, Day 14, Week 24, Week 26 and Week 52.

• Drug
  Placebo

  Placebo matching obinutuzumab will be administered by IV on Day 1, Day 14, Week 24, Week 26 and Week 52.

• Drug
  Mycophenolate Mofetil

  Mycophenolate Mofetil (MMF) will be taken by home administration orally at a target dose of 1200 mg/m\^2/day to a maximum of 2.5g/day from baseline (Day 1) onwards.

• Drug
  Acetaminophen/paracetamol

  Acetaminophen 1000 mg will be administered as pre-medication prior to infusions.

• Drug
  Diphenhydramine hydrochloride (HCl)

  Diphenhydramine HCl 50 mg will be administered as pre-medication prior to infusions.

• Drug
  Methylprednisolone

  Methylprednisolone 80 mg IV will be administered as pre-medication prior to infusions.

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