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A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study With Open-Label Extension to Assess the Efficacy and Safety of KRN23 in Adults With X-linked Hypophosphatemia (XLH)

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study With Open-Label Extension to Assess the Efficacy and Safety of KRN23 in Adults With X-linked Hypophosphatemia (XLH)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jul 2023

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At a glance

  • Drugs Burosumab (Primary)
  • Indications X-linked dominant hypophosphataemic rickets
  • Focus Registrational; Therapeutic Use
  • Sponsors Kyowa Kirin

    • Most Recent Events

    • 01 Oct 2022 Results of a post-hoc subgroup analysis assessing whether benefits of burosumab are evident in 14 clinically relevant subgroups defined by baseline demographic and functional criteria, including sex, BPI-SF average and worst pain, region, race, WOMAC R stiffness, physical function and pain domains and total score, use of opioid/other pain medication, active fractures/pseudo-fractures, and 6-min walk test distance published in the Calcified Tissue International
    • 03 Dec 2021 Results of post-hoc analysis (n=131) assessing utility change over time was estimated using asymptotic models fitted to the placebo data to week 24 from UX023-CL303, and the burosumab data to week 48 from BUR02 studies, presented at the 24th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research.
    • 24 Sep 2021 According to a Kyowa Kirin media release, data were published today in the BMJ journal RMD Open, Rheumatic and Musculoskeletal Diseases
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