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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)

Trial Profile

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)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 26 Jun 2025

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At a glance

  • Drugs Diphenhydramine (Primary) ; Methylprednisolone (Primary) ; Mycophenolate mofetil (Primary) ; Obinutuzumab (Primary) ; Paracetamol (Primary) ; Prednisone (Primary)
  • Indications Lupus nephritis
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms POSTERITY
  • Sponsors Roche

Most Recent Events

  • 26 Mar 2025 Planned End Date changed from 31 Aug 2027 to 28 Sep 2029.
  • 31 Dec 2024 Planned End Date changed from 13 Mar 2029 to 31 Aug 2027.
  • 31 Dec 2024 Planned primary completion date changed from 31 Mar 2026 to 31 Aug 2027.

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