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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 457
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Lumbar Spine BMD at Month 12
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
SB16 (Proposed Denosumab Biosimilar)
Subjects randomised into SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously every 6 months.
干预措施: SB16 (Proposed Denosumab Biosimilar) (Drug)
Prolia® (Denosumab)
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.
干预措施: SB16 (Proposed Denosumab Biosimilar) (Drug)
Prolia® (Denosumab)
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.
干预措施: Prolia® (Denosumab) (Drug)
结局指标
主要结局
Percent Change From Baseline in Lumbar Spine BMD at Month 12
时间窗: Baseline and Month 12
次要结局
未报告次要终点