A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 [Proposed Denosumab Biosimilar] to Prolia® [EU-sourced] in Postmenopausal Osteoporosis (SIMBA Study)
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- STATUS
- Recruiting
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- End date
- Mar 29, 2024
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- participants needed
- 528
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- sponsor
- mAbxience S.A
Summary
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
Description
The study will randomise approximately 528 postmenopausal women with osteoporosis aged ≥55 and ≤80 years old with a Bone Mineral Density (BMD) consistent with T-score of ≤ -2.5 and ≥ -4 at the lumbar spine or hip as measured by DXA during the Screening Period. Screening evaluations will be completed within 28 days prior to randomisation.
On Day 1, 528 eligible postmenopausal women with osteoporosis will be randomised in a 2:1:1 ratio to re-ceive MB09-MB09 (Arm 1), Prolia-MB09 (Arm 2), or Prolia-Prolia (Arm 3) using an Interactive Response Sys-tem (IRT).
During the Main Treatment Period, subjects will receive one subcutaneous injection (60 mg/mL) of study drug on Day 1 and at Month 6. At Month 12, after all efficacy and safety assessments have been performed, the subject will enter the Transition/Safety Follow Up Period and will receive the third dose of study drug. Subjects assigned to the MB09 MB09 arm (Arm 1) will receive MB09 on Day 1, at Month 6 and at Month 12. Subjects assigned to the Prolia MB09 arm (Arm 2) will receive EU-Prolia on Day 1 and at Month 6, and MB09 at Month 12. Subjects assigned to the Prolia-Prolia arm (Arm 3) will receive EU-Prolia on Day 1, at Month 6, and at Month 12. All subjects will be followed up to Transition Period Month 6.
All subjects will receive daily supplementation of calcium and vitamin D.
Details
| Condition | Postmenopausal Women With Osteoporosis |
|---|---|
| Treatment | Vitamin D, MB09 (denosumab biosimilar), EU-Prolia, Elemental Calcium |
| Clinical Study Identifier | NCT05338086 |
| Sponsor | mAbxience S.A |
| Last Modified on | 29 April 2022 |
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