EUCTR2020-001479-34-LT进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 432
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Subjects must meet all of the following criteria to be eligible for the study:
- •1.Postmenopausal women (defined as lack of menstrual period for at least 12 months prior to Screening, for which there is no other pathological or physiological cause) who are 55 to 80 years of age at Screening
- •Serum follicle stimulating hormone (FSH) test can be done at Screening in case of uncertainty.
- •2.Ambulatory and visually unimpaired to participate in the study at Screening, in the opinion of the Investigator
- •3.Absolute BMD consistent with T-score at the total hip or lumbar spine of = ?4 and = ?2.5, determined by central imaging centre at Screening
- •4.At least three evaluable vertebrae within L1 to L4, one evaluable femoral neck, and one evaluable hip joint for BMD measurement, determined by central imaging centre at Screening
- •5.Biologic (defined as any therapeutic monoclonal antibody or fusion receptor protein, including denosumab, denosumab biosimilars, or romosozumab) naïve at Screening
- •6.Body weight of = 50 kg and = 90 kg at Screening
- •7.Has provided informed consent voluntarily and must be able to, in the opinion of the Investigator, understand the implications of taking part in the study, be willing to follow the study requirements, and complete the study
- •Subjects must meet the following criteria to be enrolled in the Transition period:
- •1.Have been enrolled and completed the scheduled Month 12 of the Main period of the SB16-3001 study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 346
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 86
排除标准
- •Subjects meeting any of the following criteria are not eligible for the study:
- •1.One severe or more than two moderate vertebral fractures on spinal X-ray according to Genant classification, determined by central imaging centre at Screening
- •2.History of hip fracture or bilateral hip replacement at Screening
- •3.Uncorrected vitamin D deficiency
- •4.Hypercalcemia or hypocalcaemia at Screening
- •5.Inadequate haematological function at Screening
- •6.Inadequate renal or hepatic function at Screening
- •7.Known allergic reactions, hypersensitivity, or intolerance to denosumab or to any ingredients of the investigational product (IP), including latex allergy or hereditary problems of fructose intolerance at Screening
- •8.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
- •9.Use of any of the medications that can affect BMD
- •10.Use of any non-biologic IP that is not indicated for osteoporosis from another study or use of an investigational device at Screening
- •11.Non-osteoporosis medical conditions that can affect BMD at Screening
- •23.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
- •Subjects meeting the following criteria must not be enrolled in the Transition period:
- •1.Found to be of increased risk to continue enrolment, in the opinion of the Investigator
研究者
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