An Open-Label, Phase 2 Study to Assess the Safety, Pharmacodynamics, and Efficacy of KRN23 in Children from 1 year to less than 5 years Old 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
- Sponsors Ultragenyx Pharmaceutical
- 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 a trial in 5-12 year olds (see CT 245325) and 24-week data from this trial.
- 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).
- 02 May 2017 Planned primary completion date changed from 30 Apr 2017 to 30 Oct 2017.