Osteoporosis at High Risk of Fracture MedDRA version: 20.0 Level: PT Classification code 10031282 Term: Osteoporosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Recombinant Anti-RANKL Human Monoclonal Antibody
Product Code: HLX14
Pharmaceutical Form: Solution for injection
INN or Proposed INN: HLX14
CAS Number: 615258-40-7
Other descriptive name
Sponsors
Shanghai Henlius Biotech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all the following criteria are allowed to be enrolled: 1. Subjects voluntarily sign the informed consent form, understand the nature, objectives, and procedures of the study, and are willing to comply with the procedures during the study. 2. Ambulatory postmenopausal women with osteoporosis aged 60–90 years (both inclusive). 3. Postmenopausal, defined as > 2 years of menopause, i.e., > 2 years of spontaneous amenorrhea or > 2 years after bilateral oophorectomy. If a subject has unknown status of bilateral oophorectomy or has undergone hysterectomy but with the ovaries reserved, follicular stimulating hormone (FSH) level > 40 U/L can be used to confirm the post-operative menopausal status. 4. Bone mineral density (BMD) T-score between -2.5 and -4.0 at the lumbar spine or total hip, i.e., -4.0 5 cigarettes/day and not smoking at all for at least the last 2 years prior to screening process) or light smokers (Should be situational smokers, those who often smoke while consuming alcohol or in another type of situation, but who do not smoke daily. Light smokers should have not smoked more than 1 cigarette in the week before starting the medical screening process. 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 478 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 478
Exclusion criteria
Exclusion criteria: 1.Diseases affecting bone metabolism:osteomalacia or osteogenesis imperfecta; Paget's disease of bone; Cushing's syndrome; hyperprolactinemia; hypopituitarism; acromegaly; multiple myeloma; hyperparathyroidism; hypoparathyroidism. 2.Thyroid disorders: Hyper- or hypothyroidism; only subjects with hypothyroidism receiving stable thyroid hormone replacement therapy may be included, according to the following criteria: 1.If TSH level is below local normal range, subject is not eligible for the study. 2.If TSH level increases (> 5.5 µIU/mL but = 10.0 µIU/mL), meanwhile serum FT4 is within the normal range, subject is eligible. 3.If TSH level is > 10.0 µIU/mL, subject is not eligible for the study. 3.Rheumatoid arthritis; ankylosing spondylitis. 4.Active malignancies (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical cancer or breast ductal carcinoma in situ) within the last 5 years prior to signing the ICF. 5.Malabsorption syndrome or various gastrointestinal disorders associated with malabsorption, e.g., Crohn's disease and chronic pancreatitis, malabsorption of calcium or vitamin D. 6.Severe renal impairment due to renal disease with a glomerular filtration rate 3 years or dosing within 12 months of oral bisphosphonates prior to randomization; 3.parathyroid hormone (PTH) or PTH analogues, such as teriparatide, within 12?months prior to randomization. 4.systemic hormone replacement thera
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the equivalence of the primary clinical efficacy endpoint between HLX14 and comparator Prolia® in postmenopausal women with osteoporosis at high risk of fracture.;Secondary Objective: To assess the equivalence of secondary clinical efficacy endpoints between HLX14 and comparator Prolia® in postmenopausal women with osteoporosis at high risk of fracture. To compare the safety of HLX14 and comparator Prolia® in postmenopausal women with osteoporosis at high risk of fracture. To compare the pharmacokinetics of HLX14 and comparator Prolia® in postmenopausal women with osteoporosis at high risk of fracture. To compare the immunogenicity of HLX14 and comparator Prolia® in postmenopausal women with osteoporosis at high risk of fracture. ;Primary end point(s): Percent change from baseline in BMD at the lumbar spine to Week 52 (D365). Note: The percent change in BMD is calculated as: (Test value - Baseline value) / (Baseline Value) × 100%;Timepoint(s) of evaluation of this end point: 365 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Fracture rate from baseline to Week 52 (D365). 2. Percent change in BMD at lumbar spine from baseline to Week 26 (D183). 3. Percent change in BMD at total hip from baseline to Week 26 (D183) and Week 52 (D365). 4. Percent change in BMD at the femoral neck from baseline to Week 26 (D183) and Week 52 (D365). Note: The fracture rate is calculated as (Number of subjects with a history of fracture as of D365 - Number of subjects with a fracture at baseline) / Number of subjects with a fracture at baseline × 100% The percent change in BMD is calculated as (test value - baseline value) ÷ (baseline value) × 100%;Timepoint(s) of evaluation of this end point: 365 days | — |
Countries
Australia, China, Hong Kong, Hungary
Contacts
Public ContactJin Li
Shanghai Henlius Biotech, Inc.
Outcome results
None listed