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

Epidermal Nevus Syndrome (ENS) Clinical Trial

Official title: 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

Clinical Trial 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).

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Epidermal Nevus Syndrome (ENS)
• Neoplasms, Connective Tissue
• Nevus
• Osteomalacia
• Syndrome
• Tumor Induced Osteomalacia (TIO)

• NCT number: NCT02304367
• Study type: Interventional
• Source: Kyowa Kirin Co., Ltd.
• Status: Completed
• Phase: Phase 2
• Start date: March 24, 2015
• Completion date: January 21, 2021