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Clinical Trial Summary

Before switching to the post-marketing study: To evaluate the efficacy and safety of KRN23 after its 144-week once every 4 weeks (Q4W) repeated SC administration to Japanese and Korean patients with TIO or ENS by a multicenter, open-label, intraindividual dose adjustment study. After switching to the post-marketing study: To evaluate the safety and efficacy of KRN23, which is switched from the investigational product to the post-marketing investigational product, at the approved dose and dosing regimen in subjects who continue treatment after the marketing approval of KRN23 in Japan.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT02722798
Study type Interventional
Source Kyowa Kirin Co., Ltd.
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Status Completed
Phase Phase 2
Start date April 2016
Completion date October 2020