drugset / Trial / NCT02304367

Study of Burosumab (KRN23) in Adults With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)

NCT02304367

Phase 2 Completed 17 enrolled Kyowa Kirin, Inc.
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2015-03-24
Primary completion
2017-07-27
Completion
2021-01-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Burosumab Monoclonal antibody Subcutaneous