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ea0070aep122 | Bone and Calcium | ECE2020

Phase 3b open-label study of burosumab in adults with X-linked hypophosphatemia (XLH): Baseline and Week 12 results

Kamenický Peter , Javaid Kassim , Keen Richard , Lachmann Robin , Ralston Stuart , Cohen-Solal Martine , Brandi Maria , Briot Karine , Crowley Rachel , Walsh Jennifer , Kolta Sami , Rylands Angela , Sun Wei , Nixon Annabel

Introduction: Burosumab, a fully human monoclonal antibody to fibroblast growth factor 23 (FGF23), is the only approved treatment for XLH, a rare genetic disorder characterized by renal phosphate wasting and substantial cumulative musculoskeletal morbidity. BUR02 (NCT03920072) is a European phase 3b open-label study monitoring the long-term safety and efficacy of burosumab in adults with XLH from sites who participated in the CL303/CL304 studies (NCT02526160/02537431).<p c...

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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

Phase 3b open-label study of burosumab in adults with X-linked hypophosphatemia (XLH): Baseline and Week 12 results

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)

BiosciAbstracts