At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1 enrolled
Drug / intervention
Burosumabbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Trial to Assess the Safety and Efficacy of Burosumab (KRN23), an Investigational Antibody to FGF23, in a Single Pediatric Patient With Epidermal Nevus Syndrome(ENS) and Associated Hypophosphatemic Rickets
In Brief
A Phase 3 clinical trial evaluating Burosumab for Hypophosphatemia and 2 related conditions. Completed, enrolled 1 participant across 1 site.
Detailed Summary
A 52 week, open label trial to assess the safety and efficacy of KRN23, an investigational antibody to FGF23, in a single pediatric patient with Epidermal Nevus Syndrome(ENS) and associated hypophosphatemic rickets A 26 weeks extension to original study to monitor patient lab results for her safety.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypophosphatemia, Hypophosphatemic Rickets, Pain, Chronic
CountriesUnited States
CollaboratorsUltragenyx Pharmaceutical Inc
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartJan 2018
First PostedJul 2018
Primary CompletionDec 2019
TodayJul 2026
First PostedJul 10, 2018
Enrollment StartJan 31, 2018
Primary CompletionDec 6, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.0 years ago
Interventions
Burosumabbiological
recombinant human IgG1 monoclonal antibody to fibroblast growth factor 23)