At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 17 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.
A Phase 2 Open-Label Trial to Assess the Efficacy and Safety of KRN23, an Antibody to FGF23, in Subjects With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)-Associated Osteomalacia
In Brief
A Phase 2 clinical trial evaluating Burosumab for Tumor Induced Osteomalacia (TIO) and Epidermal Nevus Syndrome (ENS). Completed, enrolled 17 participants across 7 sites.
Detailed Summary
The primary objectives of this study are to evaluate the effect of burosumab treatment on: * Increasing serum phosphorus levels in adults with TIO or ENS-associated osteomalacia * Improvement in TIO/ENS-associated osteomalacia as determined by osteoid thickness (O.Th), osteoid surface/bone surface (OS/BS), osteoid volume/bone volume (OV/BV) and mineralization lag time (MLt).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 2014
Enrollment StartMar 2015
Primary CompletionJul 2017
Study CompletionJan 2021
TodayJul 2026
First PostedDec 1, 2014
Enrollment StartMar 24, 2015
Primary CompletionJul 27, 2017
Study CompletionJan 21, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.6 years ago
Interventions
Burosumabbiological
Solution for subcutaneous injection