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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

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Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Feb 2026

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At a glance

  • Drugs Obinutuzumab (Primary) ; Buclizine; Codeine phosphate; Diphenhydramine; Methylprednisolone; Mycophenolate mofetil; Paracetamol; Prednisolone; Prednisone
  • Indications Lupus nephritis
  • Focus Registrational; Therapeutic Use
  • Acronyms REGENCY
  • Sponsors Roche

Most Recent Events

  • 26 Jan 2026 According to a Roche media release, the company announced that on January 22, 2026, Health Canada has approved Gazyva (obinutuzumab) for the treatment of adult patients with active lupus nephritis who are receiving standard therapy.
  • 09 Dec 2025 According to a Roche media release, the company announced that the European Commission has approved Gazyva/Gazyvaro (obinutuzumab) in combination with mycophenolate mofetil (MMF) for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis.
  • 06 Nov 2025 Planned End Date changed from 28 Feb 2028 to 28 Feb 2031.

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