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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 (REGENCY)

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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 (REGENCY)

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

Latest Information Update: 23 Apr 2025

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At a glance

  • Drugs Obinutuzumab (Primary) ; Methylprednisolone; Mycophenolate mofetil; Prednisone
  • Indications Lupus nephritis
  • Focus Registrational; Therapeutic Use
  • Acronyms REGENCY
  • Sponsors Roche

Most Recent Events

  • 21 Apr 2025 According to Northwell Health's Feinstein Institutes for Medical Research media release, the data from this study has been published showcasing significantly higher percentage of participants in the obinutuzumab group achieved a complete renal response compared to the placebo group, in The New England Journal of Medicine.
  • 09 Apr 2025 Planned End Date changed from 28 Feb 2029 to 28 Feb 2028.
  • 05 Mar 2025 According to Roche media release, company announced that the US FDA has accepted the company supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis. The filing acceptance is based on positive results from the phase III REGENCY study. The FDA is expected to make a decision on approval by October 2025.

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