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)

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)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Apr 2018

At a glance

  • Drugs Burosumab (Primary)
  • Indications X-linked dominant hypophosphataemic rickets
  • Focus Registrational; Therapeutic Use
  • Sponsors Ultragenyx Pharmaceutical
  • Most Recent Events

    • 17 Apr 2018 According to the Ultragenyx Pharmaceutical media release, The U.S. Food and Drug Administration (FDA) has approved Crysvita (burosumab-twza) for the treatment of X-linked hypophosphatemia (XLH) in adult patients and has granted priority review status, based on the data from this study.
    • 20 Mar 2018 Results (n=134) assessing the efficacy of KRN-23 in adults with X-linked hypophosphataemia, were presented at The 100th Annual Meeting of the Endocrine Society.
    • 13 Feb 2018 Planned End Date changed from 6 Mar 2018 to 30 Sep 2018.
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