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ea0056oc3.1 | New insights in bone disorders | ECE2018

A Phase 3 randomized, double-blind, placebo-controlled study investigating the efficacy and safety of Burosumab, an anti-FGF23 antibody, in adult X-Linked Hypophosphatemia (XLH)

Kamenicky Peter , Lachmann Robin , Carpenter Thomas O. , Cohen-Solal Martine , Eastell Richard , Brandi Maria Luisa , Crowley Rachel K. , Ralston Stuart H. , Javaid Muhammad K. , Keen Richard , Briot Karine , Il Cheong Hae , Imanishi Yasuo , Ito Nobuaki , Tanaka Hiroyuki , Zhang Lin , Theodore-Oklota Christina , Mealiffe Matt , Martin Javier San , Insogna Karl L.

UX023-CL303 is an ongoing, Phase 3, double-blind, multicenter study examining the efficacy and safety of burosumab, a fully human monoclonal antibody against FGF23, in adults with XLH. Eligible subjects had serum phosphorus levels <0.81 mmol/l and skeletal pain (BPI Worst Pain ≥4). Subjects (N=134) were randomized 1:1 to receive burosumab 1 mg/kg or placebo subcutaneously every 4 weeks. After 24 weeks, subjects in the placebo group crossed-over to rec...

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Endocrine Abstracts

A Phase 3 randomized, double-blind, placebo-controlled study investigating the efficacy and safety of Burosumab, an anti-FGF23 antibody, in adult X-Linked Hypophosphatemia (XLH)

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