A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis

Study Overview
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Brief Summary
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This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK, PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.

Detailed Description
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Subjects will be randomised in a 1:1 ratio to receive either SB16 or Prolia®. At Month 12, subjects in Prolia® treatment group will be randomised again in a 1:1 ratio to either continue on Prolia® treatment or be transitioned to SB16 treatment. Investigational product (60 mg in 1 mL of SB16 or Prolia®) will be given subcutaneously every 6 months up to Month 12, and the last assessment will be done at Month 18.

Official Title
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A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Compare the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Between SB16 (Proposed Denosumab Biosimilar) and Prolia® in Postmenopausal Women With Osteoporosis

Conditions
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Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: SB16 (Proposed Denosumab Biosimilar)
* Drug: Prolia® (Denosumab)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal women who are 55 to 80 years of age at Screening Ambulatory and visually unimpaired to participate in the study at Screening, in the opinion of the Investigator Absolute BMD consistent with T-score at the total hip or lumbar spine of -4 and -2.5 at Screening At least three evaluable vertebrae within L1 to L4, one evaluable femoral neck, and one evaluable hip joint for BMD measurement at Screening Biologic naïve at Screening Body weight of 50 kg and 90 kg at Screening Exclusion Criteria: One severe or more than two moderate vertebral fractures on spinal X-ray according to Genant classification at Screening History of hip fracture or bilateral hip replacement at Screening Uncorrected vitamin D deficiency at Screening Hypercalcemia or hypocalcaemia at Screening Inadequate haematological function at Screening Inadequate renal or hepatic function at Screening Known allergic reactions, hypersensitivity, or intolerance to denosumab or to any ingredients of the IP, including latex allergy or hereditary problems of fructose intolerance at Screening May not tolerate long-term calcium or vitamin D supplementation or subject with malabsorption of calcium or vitamin D supplements, in the opinion of the Investigator, at Screening Use of any of the medications that can affect BMD Use of any non-biologic IP that is not indicated for osteoporosis from another study or use of an investigational device at Screening Non-osteoporosis medical conditions that can affect BMD at Screening Any clinically significant disease or disorder or laboratory abnormality which, in the opinion of the Investigator, would prevent the subject from completing the study or the interpretation of the study results at Screening and Randomisation

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB16 (Proposed Denosumab Biosimilar)<br>Subjects randomised into SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously every 6 months. | Drug: SB16 (Proposed Denosumab Biosimilar)<br>* Subjects randomised into SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously every 6 months. At Month 12, subjects transited from Prolia® group to SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously.<br>|
| Active Comparator: Prolia® (Denosumab)<br>Subjects randomised into Prolia® group will receive Prolia® (60 mg in 1 mL) subcutaneously every 6 months. At Month 12, subjects in Prolia® treatment group will be re-randomised in a 1:1 ratio to either continue on Prolia® treatment or be transitioned to SB16 treatment. After re-randomisation, subjects transited to SB16 group will receive SB16, and subjects remaining in Prolia® group will continue to receive Prolia® at Month 12. | Drug: SB16 (Proposed Denosumab Biosimilar)<br>* Subjects randomised into SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously every 6 months. At Month 12, subjects transited from Prolia® group to SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously.<br>Drug: Prolia® (Denosumab)<br>* Subjects randomised into Prolia® group will receive Prolia® (60 mg in 1 mL) subcutaneously every 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline in lumbar spine BMD at Month 12 |  | Baseline and Month 12 |