NCT04934072已完成3 期
A Double-blind, Randomized, Multicenter, Multiple-dose, 2-arm, Parallel-group Study to Evaluate Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 - Proposed Biosimilar to Denosumab With Prolia® in Postmenopausal Women With Osteoporosis (LUMIADE-3 Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 553
- 试验地点
- 67
- 主要终点
- Percentage Change From Baseline in LS-BMD by DXA
研究概览
简要总结
The primary objective of this study is to demonstrate equivalent efficacy of the proposed biosimilar denosumab FKS518 to US-licensed Prolia in women with postmenopausal osteoporosis (PMO).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Disease-related
- •History and/or presence of 1 severe or >2 moderate vertebral fractures or hip fracture confirmed by x-ray.
- •Presence of active healing fracture at screening.
- •History and/or presence of bone-related disorders, such as but not limited to Paget's disease, osteomalacia, hyperparathyroidism (or parathyroid disorders), or renal osteodystrophy.
- •Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures (eg, tooth extraction, dental implants, or oral surgery in the past 6 months), poor oral hygiene, periodontal, and/or pre-existing dental disease as assessed by the Investigator.
- •Evidence of hypocalcemia (albumin-adjusted serum calcium <2.13 mmol/L or <8.5 mg/dL) or hypercalcemia (albumin-adjusted serum calcium >2.6 mmol/L or >10.5 mg/dL) as assessed by the central laboratory at screening.
- •Vitamin D deficiency (25-hydroxy vitamin D levels <12 ng/mL) as assessed by central laboratory at screening (retest is allowed once).
- •Known intolerance to calcium or vitamin D supplements.
- •Other Medical Conditions
- •Known or suspected clinically relevant drug hypersensitivity to any components of the study drug, comparable drugs, or to latex.
- •Renal impairment: creatinine clearance <30 mL/min at screening or receiving dialysis.
- •Medical evidence of current or history of primary or secondary immunodeficiency.
- •Infection-related exclusions as further defined in the protocol.
- •Major surgical procedure within 8 weeks prior to the screening or scheduled during the study.
- •Current or history of any malignancy, or myeloproliferative, or lymphoproliferative disease within 5 years before screening.
- •History of clinically significant drug or alcohol abuse within the last year prior to randomization.
- •Prior denosumab (Prolia, Xgeva, or proposed denosumab biosimilar) exposure.
- •Prior use of fluoride within the 5 years before inclusion in the study.
- •Any current or prior use of strontium ranelate.
- •Any current or prior use of intravenous bisphosphonates.
- •Current or prior use of teriparatide and other parathormone (PTH) analogues within 12 months before screening.
- •Current or prior use of systemic oral or transdermal estrogen or selective estrogen receptor modulators or tibolone within 6 months before screening.
- •Current or prior use of calcitonin or cinacalcet within 3 months before screening or any cathepsin K inhibitor (eg, odanacatib) within 18 months before screening.
- •Current or prior use of romosozumab or antisclerostin antibody.
- •Current or prior use of other osteoporotic agents used for the prevention or treatment of osteoporosis.
- •Current use within 3 months before screening of any medication with known influence on the skeletal system (eg, systemic corticosteroids, heparin, lithium, etc) with exceptions described in the protocol.
- •Concomitant treatment with another biologic drug.
- •Have received a COVID-19 vaccine within 4 weeks before randomization or COVID-19 vaccination is ongoing at the time of screening.
研究组 & 干预措施
FKS518
Experimental
FKS518 was administered on Day 1, and then every 26 weeks (6 months), i.e., Week 26 and Week 52, at a dose of 60 mg for a total of 3 administrations.
干预措施: FKS518 (Drug)
US-Prolia
Active Comparator
US-Prolia was administered on Day 1, and then every 26 weeks (6 months), i.e., Week 26 and Week 52, at a dose of 60 mg for a total of 3 administrations.
干预措施: US-licensed Prolia (Amgen) (Drug)
结局指标
主要结局
Percentage Change From Baseline in LS-BMD by DXA
时间窗: Baseline and Week 52
Bone density was measured at the lumbar spine from L1 through L4. Per FDA request for this study, data were analyzed by non-inferiority and non-superiority analyses. Decreased BMD is associated with risk of fracture.
次要结局
- Area Under the Effect Curve (AUEC) of Serum C-terminal Cross-linking Telopeptide of Type 1 Collagen (CTX)(Baseline to Week 26)
- Percentage Change From Baseline in BMD at Femoral Neck and Total Hip by DXA(Baseline and Week 52)
- Percentage Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)(Baseline and Week 52 pre dose)
- Percentage Change From Baseline in Serum C-terminal Cross-linking Telopeptide of Type 1 Collagen (CTX)(Baseline and Week 52 pre dose)
- Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)(Day 1 to Week 78)
- Number of Participants Who Experienced a Treatment-Emergent Serious Adverse Event (TESAE)(Day 1 to Week 78)
- Number of Participants Who Experienced a Treatment-emergent Adverse Event of Special Interest (AESI)(Day 1 to Week 78)
- Number of Participants Who Experienced an Injection Site Reaction (ISR)(Day 1 to Week 78)
研究者
研究点 (67)
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