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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab plus Standard of Care versus Placebo plus Standard of Care in Adult Subjects with Active Lupus Nephritis

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab plus Standard of Care versus Placebo plus Standard of Care in Adult Subjects with Active Lupus Nephritis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Dec 2023

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At a glance

  • Drugs Belimumab (Primary) ; Azathioprine; Cyclophosphamide; Methylprednisolone; Mycophenolate; Steroids
  • Indications Lupus nephritis
  • Focus Registrational; Therapeutic Use
  • Acronyms BLISS-LN
  • Sponsors GlaxoSmithKline; GSK; Human Genome Sciences

Most Recent Events

  • 18 Jul 2023 Results of post hoc analysis, assess belimumab efficacy on kidney-related outcomes in newly diagnosed and relapsed LN subgroups, and according to use of glucocorticoid pulses at induction, published in the Nephrology Dialysis Transplantation
  • 01 Mar 2023 Results of prespecified subgroup analysis (n=142) assessing the efficacy and safety of belimumab in the BLISS-LN East Asian subgroup, published in the American Journal of Kidney Diseases.
  • 01 Nov 2022 Results(n=255 of Open-Label Extension of BLISS-LN Study) assessing Safety and Efficacy of Belimumab in Patients with Lupus Nephritis published in the Clinical Journal of The American Society of Nephrology: CJASN

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