A Randomised, Double-blind, Parallel, Multicentre, Multinational Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 (Proposed Denosumab Biosimilar) Versus Prolia® (EU-sourced) in Postmenopausal Women With Osteoporosis (SIMBA Study)

MB09-C-01-19

This is a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 versus Prolia® in postmenopausal women with osteoporosis

2022-03-31

2023-12-14

2024-06-01

Active (not recruiting)

Early phase I

528

Inclusion Criteria: * Postmenopausal women, diagnosed with osteoporosis. * Aged ≥ 55 and ≤ 80 years at screening. * Body weight ≥ 50 kg and ≤ 99.9 kg, and a body mass index of ≤30 kg/m2 at screening. * Absolute bone mineral density consistent with T-score ≤ -2.5 and ≥ -4.0 at the lumbar spine or total hip as measured by DXA. * At least two intact, nonfractured vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA. * Adequate organ function. Exclusion Criteria: * Previous exposure to denosumab (Prolia®, Xgeva®, or denosumab biosimilar) or other monoclonal anti-body. * History and/or presence of one severe or more than two moderate vertebral fractures or hip fracture. * Recent long bone fracture (6 months). * History and/or presence of bone metastases, bone disease or other metabolic disease. * Ongoing use of any osteoporosis treatment or use of prohibited treatment. * Other bone active drugs. * History and/or current hypoparathyroidism or hyperparathyroidism, hypocalcemia or hypercalcemia. * Other Inclusion/exclusion criteria may apply.

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2024-04-26