NCT02304367

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Kyowa Kirin, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Tumor Induced Osteomalacia (TIO)
• Epidermal Nevus Syndrome (ENS)

Interventions

Type	Name	Description
BIOLOGICAL	Burosumab	Solution for subcutaneous injection

Timeline

• Start date: 2015-03-24
• Primary completion: 2017-07-27
• Completion: 2021-01-21
• First posted: 2014-12-01
• Last updated: 2024-05-06
• Results posted: 2020-07-30

Locations

7 sites across 1 country: United States