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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)

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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)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 19 Sep 2024

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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

    • 03 Nov 2023 Number of treatment arms have been increased from 2 to 3 by the addition of Experimental: Open-Label Obinutuzumab arm for a younger participant cohort. A safety end-point is also added. Lower age limit for inclusion criteria is reduced from 12 to 5 years.
    • 03 Nov 2023 Planned number of patients changed from 30 to 40.
    • 03 Nov 2023 Planned End Date changed from 13 Mar 2027 to 13 Mar 2029.

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