At a glance
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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis
In Brief
A Phase 3 clinical trial evaluating Obinutuzumab, MMF, and 5 other interventions for Lupus Nephritis. Active but no longer recruiting, targeting 271 participants across 74 sites in 15 countries.
Detailed Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in participants with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.
Study Details
Timeline
Interventions
Obinutuzumab will be administered by IV infusion at a dose of 1000 mg at Baseline and Weeks 2, 24, 26, 50 (group 2: placebo), and 52 and subsequently from Week 80 and every 6 months thereafter, based on response.
MMF willl be administered at a target dose of 2.0 - 2.5 g/day in divided doses through Week 80.
Prednisone 0.5 mg/kg/day (maximum 60 mg/day) will be started on Day 2. Beginning on Day 15, prednisone will be tapered to 5 mg/day and continued until Week 80.
Placebo matching obinutuzumab will be administered by IV infusion at baseline and Weeks 0, 2, 24, 26, 50 and 52 and subsequently from Week 80 and every 6 months thereafter based on response.
Methylprednisolone 80 mg IV will be administered as predmedication prior to infusions.
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
Diphenhydramine 50 mg will be administered as premedication prior to infusions.