A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 [Proposed Denosumab Biosimilar] to Prolia® [EU-sourced] in Postmenopausal Osteoporosis (SIMBA Study)

  • STATUS
    Recruiting
  • End date
    Mar 29, 2024
  • participants needed
    528
  • sponsor
    mAbxience S.A
Updated on 29 April 2022

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 IdentifierNCT05338086
SponsormAbxience S.A
Last Modified on29 April 2022

Eligibility

Yes No Not Sure

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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