Postmenopausal osteoporosis MedDRA version: 20.0 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Samsung Bioepis Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the equivalence of SB16 to Prolia®, in terms of percent change from baseline in lumbar spine bone mineral density (BMD) at Month 12 in subjects with postmenopausal osteoporosis (PMO).;Secondary Objective: To evaluate the efficacy of SB16 compared to Prolia® by -Percentage change from baseline in lumbar spine BMD -Percentage change from baseline in total hip BMD -Percentage change from baseline in femoral neck BMD To evaluate the safety and tolerability of SB16 compared to Prolia® To evaluate the pharmacokinetic (PK) profile of SB16 compared to Prolia® To evaluate the pharmacodynamic (PD) profile of SB16 compared to Prolia® To evaluate the immunogenicity of SB16 compared to Prolia® To evaluate the safety, tolerability, immunogenicity, PK, PD, and efficacy in subjects with PMO who transitioned to SB16 from Prolia® compared to subjects who maintained Prolia® from the Main period;Primary end point(s): Percent change from baseline in lumbar spine BMD ;Timepoint(s) of evaluation of this end point: Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints for the Main period Efficacy endpoints -Percent change from baseline in lumbar spine BMD -Percent change from baseline in total hip BMD -Percent change from baseline in femoral neck BMD Safety endpoints -Incidence of adverse events (AEs) -Incidence of serious AEs (SAEs) PK endpoint -Serum drug concentration PD endpoints -Serum C-telopeptide of type I collagen (CTX) concentration -Area under the effect curve from time zero to Month 6 (AUEC0-M6) of percent change from baseline in serum CTX -Serum procollagen type I N-terminal propeptide (P1NP) concentration Immunogenicity endpoint -Incidence of anti-drug antibodies (ADAs) -Incidence of neutralising antibodies (NAbs) Secondary endpoints for the Transition period Safety endpoints -Incidence of AEs -Incidence of SAEs Immunogenicity endpoint -Incidence of ADAs and NAbs Efficacy endpoints -Percent change from baseline in lumbar spine BMD -Percent change from baseline in total hip BMD -Percent change from baseline in femoral neck BMD PK endpoint -Serum drug concentration PD endpoint -Serum CTX concentration -Serum P1NP concentration;Timepoint(s) of evaluation of this end point: Secondary endpoints for the Main period Safety endpoints during whole study Efficacy endpoints -Percent change from baseline in lumbar spine BMD at Month 6 -Percent change from baseline in total hip BMD at Month 6 and 12 -Percent change from baseline in femoral neck BMD at Month 6 and 12 PK endpoint at Months 0, 0.5, 1, 3, 6, 9, and 12 PD endpoints -Serum CTX at Months 0, 0.5, 1, 3, 6, 9, and 12 -AUEC0-M6 at Month 6 -Serum P1NP at Months 0, 0.5, 1, 3, 6, 9, and 12 Immunogenicity endpoint -Incidence of ADAs at Months 0, 0.5, 1, 3, 6, 9, and 12 -Incidence of NAbs at Months 0, 0.5, 1, 3, 6, 9 and 12 Secondary endpoints for the Transition period Safety endpoints during whole study Immunogenicity, efficacy, PK and PD endpoints at Month 18 | — |
Countries
Bulgaria, Czechia, Czech Republic, Denmark, Hungary, Korea, Republic of, Lithuania, Poland
Contacts
Public ContactInformation Desk
Samsung Bioepis Co., Ltd.
Outcome results
None listed