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ILLUMINATE-B: An Open-Label Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Lumasiran in Infants and Young Children with Primary Hyperoxaluria Type 1

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Trial Profile

ILLUMINATE-B: An Open-Label Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Lumasiran in Infants and Young Children with Primary Hyperoxaluria Type 1

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

Latest Information Update: 27 Mar 2024

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At a glance

  • Drugs Lumasiran (Primary)
  • Indications Primary hyperoxaluria type 1
  • Focus Registrational; Therapeutic Use
  • Acronyms ILLUMINATE-B
  • Sponsors Alnylam Pharmaceuticals

    • Most Recent Events

    • 27 Feb 2023 Results of 12-months analysis were published in the Pediatric Nephrology.
    • 06 Oct 2022 According to an Alnylam Pharmaceuticals media release, the USFDA has approved a label expansion for OXLUMO (lumasiran), indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate (UOx) and plasma oxalate (POx) levels in pediatric and adult patients. The approval is based on results of this trial.
    • 18 May 2022 Primary endpoint has been met. (Percentage Change in Urinary Oxalate Excretion from Baseline to Month 6), according to an Alnylam Pharmaceuticals media release.
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