Postmenopausal osteoporosis MedDRA version: 20.0 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: LY06006, proposed denosumab biosimilar
Product Code: LY06006
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Denosumab
CAS Number: 615258-40-7
Curr
Sponsors
Shandong Boan Biotechnology Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria are met: 1. Participant is = 55 to = 90 years of age inclusive (upper age limit of 75 years inclusive, for participants in Czech Republic only), at the time of signing the informed consent. 2. Participant is an ambulatory postmenopausal woman (defined as lack of menstrual period for at least 12 months prior to Screening Visit, for which there is no other obvious pathological or physiological cause). - Serum FSH test can be done at the Screening Visit in case of uncertainty - Female participants who underwent bilateral oophorectomy (with or without hysterectomy) at least 6 weeks prior to the Screening Period are eligible to participate. 3. Participant is diagnosed with osteoporosis, with absolute BMD consistent with a T-score of = -2.5 and = -4.0 at the lumbar spine (L1-L4 region) as measured by DXA at the Screening Visit. 4. Participant has at least two lumbar vertebrae in L1-L4 region and one hip evaluable by DXA for BMD measurement at the Screening Visit. 5. Participant has body weight = 50 kg and = 90 kg at Screening. 6. Participant is able to read and understand, and willing to provide signed informed consent as described in Appendix 1, Section 10.1.3 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. 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 399 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 125
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria are met: 1. Participant has a history of any severe or more than two moderate vertebral fractures as determined by central reading of lateral spine X-ray at Screening Visit. 2. Participant has a history and/or presence of hip fracture. 3. Participant has a history and/or presence of atypical femur fracture. 4. Participant presents with any active healing fracture, per assessment of the Investigator. 5. Participant has a history of bilateral hip replacement (unilateral is allowed if the other hip is evaluable by DXA). 6. Participant has history and/or presence of osteonecrosis of the external auditory canal. 7. Evidence of any of the following conditions which may affect BMD or interfere with the interpretation of the findings: a. Participant has a history of bone disease e.g., osteomalacia, osteopetrosis, Paget’s disease, or osteogenesis imperfecta. b. Participant has a history of metabolic or other endocrinologic diseases such as Cushing’s disease, hyperprolactinemia, hypopituitarism, acromegaly, malabsorption syndrome (or any gastrointestinal disorders associated with malabsorption, e.g., Crohn’s disease and chronic pancreatitis). c. Participant has a history of chronic inflammatory diseases, obvious sclerosis, osteophytosis, severe scoliosis, or other degenerative changes due to other co-morbidities. d. Participant has a history or current hyperparathyroidism or hypoparathyroidism. Note: Mild non-clinically significant secondary hyperparathyroidism may be acceptable upon discussion with the Medical Monitor. e. Participant has current uncontrolled hyperthyroidism or hypothyroidism. Note: Participants with hypothyroidism who are on stable thyroid hormone replacement therapy may be allowed per the following criteria: • If TSH level is within normal range, the participant is eligible. • If TSH level is elevated (> upper limit of normal and = 10.0 µIU/mL) and serum free T4 is within normal range, the participant is eligible. If a marginally low TSH level results from the therapy, the participant may be enrolled after discussion with the Medical Monitor. Note: 2) If TSH is marginally out of normal range, serum free T4 is within normal range, and there are no plausible medical conditions resulting in abnormal TSH level, the participant may be enrolled with the approval from the Medical Monitor. f. Participant has other disease conditions where there is bone/joint involvement (e.g., rheumatoid arthritis, ankylosing spondylitis, gout, multiple myeloma, achondroplasia, bone metastases, renal osteodystrophy, osteomyelitis). 8. Participant has hypocalcemia (defined as albumin adjusted serum calcium level 2.62 mmol/L [10.50 mg/dL]). 9. Participant has vitamin D deficiency (defined as 25-hydroxy vitamin D level < 20 ng/mL [< 50 nmol/L]). Note: Oral replenishment of vitamin D is permitted at the discretion of the Investigator and in accordance with local standard of care during the Screening Period. Participants can be enrolled if a repeat test (post supplementation) prior to enrollment shows corrected 25-hydroxy vitamin D level = 20 ng/mL (= 50 nmol/L). 10. Participant has any malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years. 11. Participant has known history of liver cirrhosis. 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - All regions: To demonstrate equivalent efficacy between LY06006 and EU-Prolia, in terms of BMD in female participants with postmenopausal osteoporosis. - EU filing only: To demonstrate similar PD between LY06006 and EU-Prolia, in terms of the bone resorption marker sCTX in female participants with postmenopausal osteoporosis ;Secondary Objective: - To provide additional comparative efficacy data of LY06006 with EU-Prolia in female participants with postmenopausal osteoporosis - To provide additional comparative PD data on LY06006 with EU-Prolia in female participants with postmenopausal osteoporosis - To evaluate the safety of LY06006 compared to EU-Prolia in female participants with postmenopausal osteoporosis - To evaluate the PK profile of LY06006 compared to EU-Prolia in female participants with postmenopausal osteoporosis - To evaluate the immunogenicity of LY06006 compared to EU-Prolia in female participants with postmenopausal osteoporosis ;Primary end point(s): Primary endpoint: - %CfB in lumbar spine BMD at Month 12 - Co-primary endpoint for the EU filing only: standardized AUEC0-6m (post first dose) of -%CfB in bone resorption marker sCTX over 6 months ;Timepoint(s) of evaluation of this end point: Month 12 and Month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • %CfB in lumbar spine BMD at Month 6 • %CfB in total hip BMD at Months 6 and 12 • %CfB in femoral neck BMD at Months 6 and 12 • %CfB in sCTX at Months 0.5, 1, 2, 3, 6, and 12 • %CfB in sP1NP at Months 1, 6, and 12. • AEs, including SAEs • Vital signs • Physical and dental examination • Clinical laboratory tests (hematology, clinical chemistry, and urinalysis) • 12-lead ECG • Injection site reaction assessment • Serum drug concentrations at baseline and at Months 0.5, 1, 2, 3, 6, 9, and 12 • Incidence of ADAs at baseline and at Months 0.5, 1, 2, 3, 6, 9, and 12 • Incidence of NAbs at baseline and at Months 0.5, 1, 2, 3, 6, 9, and 12 • Serum drug concentrations, incidence of ADAs, incidence of NAbs at baseline (Month 12) and Months 15 and 18;Timepoint(s) of evaluation of this end point: During whole study | — |
Countries
Bulgaria, Czechia, Czech Republic, Japan, Poland, United States
Contacts
Public ContactClinical Trials Information
Parexel International LLC
Outcome results
None listed