At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 134 enrolled
Drug / intervention
burosumab +1 morebiological
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 Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study With Open-Label Extension to Assess the Efficacy and Safety of KRN23 in Adults With X-linked Hypophosphatemia (XLH)
In Brief
A Phase 3 clinical trial evaluating burosumab and Placebo for X-linked Hypophosphatemia. Completed, enrolled 134 participants across 25 sites in 7 countries.
Detailed Summary
The primary efficacy objective of this study is to establish the effect of burosumab treatment compared with placebo on increasing serum phosphorus levels in adults with XLH.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsX-linked Hypophosphatemia
CountriesFrance, Ireland, Italy, Japan, South Korea, United Kingdom, United States
CollaboratorsKyowa Kirin Co., Ltd.
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartOct 2015
Primary CompletionDec 2016
Study CompletionDec 2018
TodayJul 2026
First PostedAug 18, 2015
Enrollment StartOct 22, 2015
Primary CompletionDec 22, 2016
Study CompletionDec 6, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.9 years ago
Interventions
burosumabbiological
solution for SC injection
Placeboother
saline solution for SC injection