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impe0096p21 | Bone, Growth Plate and Mineral Metabolism | IMPE2023

Orbit: A Randomized Phase 2/3 Study Consisting of a Phase 2 Single-Blind, Dose-Evaluation Phase and a Phase 3, Double-Blind, Placebo-controlled Phase to Assess the Efficacy and Safety of Setrusumab in Subjects with Osteogenesis Imperfecta

Bishop Nicholas , Rush Eric , Reid Sutton V , Sangiorgi Luca , Semler Oliver , Gottesman Gary , Cassinelli Hamilton , Mistry Arun , MacKinnon Alastair , Wang Hui , Putnam Wendy , Carrabs Maurilia , Byers Heather

Setrusumab is a fully human anti-sclerostin monoclonal antibody in development for the treatment of osteogenesis imperfecta (OI). In a Phase 2b study in adults with OI, setrusumab demonstrated robust increases in bone formation, density and strength across OI Types I, III, and IV (NCT03118570). The Orbit study is an operationally seamless Phase 2/3 clinical trial assessing the efficacy and safety of setrusumab in pediatric and young adult participants with OI (NCT0512...

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Orbit: A Randomized Phase 2/3 Study Consisting of a Phase 2 Single-Blind, Dose-Evaluation Phase and a Phase 3, Double-Blind, Placebo-controlled Phase to Assess the Efficacy and Safety of Setrusumab in Subjects with Osteogenesis Imperfecta

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