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)

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)

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 28 Jul 2017

At a glance

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

    • 28 Jul 2017 According to a Kyowa Hakko Kirin media release, submission of a BLA for burosumab for the treatment of pediatric and adult XLH patients planned in August 2017. Specifically for pediatric patients, the filing will include the 64-week data from this trial in 5-12 year olds and 24-week data from a phase 2 study in 1- 4 year olds (see CT profile 270513).
    • 23 Jun 2017 According to an Ultragenyx Pharmaceutical media release, data from this study will be submitted to support the Biologics License Application (BLA) filing of burosumab (KRN23) for X-linked hypophosphatemia (XLH).
    • 06 Apr 2017 Primary endpoint (Functional Measurements: 6 Minute Walk Test (6MWT)) has been met, according to an Ultragenyx media release.
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