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A Randomized, Open-Label, Dose Finding, Phase 2 Study to Assess the Pharmacodynamics and Safety of the Anti-FGF23 Antibody, KRN23, in Pediatric Patients With X-linked Hypophosphatemia (XLH)

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Trial Profile

A Randomized, Open-Label, Dose Finding, Phase 2 Study to Assess the Pharmacodynamics and Safety of the Anti-FGF23 Antibody, KRN23, in Pediatric Patients With X-linked Hypophosphatemia (XLH)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 24 Jul 2023

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At a glance

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

Most Recent Events

  • 12 Oct 2021 Results published in the Journal of Clinical Endocrinology and Metabolism
  • 01 Jul 2021 Results assessing the reliability, validity, and sensitivity to change of the RGI-C were evaluated using data from two studies (NCT02163577, NCT02915705) in pediatric XLH published in the Bone
  • 06 Dec 2018 According to an Ultragenyx Pharmaceutical media release, Crysvita is now approved in the United States, Europe and Canada, all within one year, and Ultragenyx and Kyowa Kirin are pursuing regulatory filings in other countries to ensure that Crysvita is available to patients with XLH around the world as quickly as possible.

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