NCT05345691已完成3 期
A Randomized, Double-Blind, Multicenter, Parallel-Arm Phase 3 Study to Compare the Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis
Biocon Biologics UK Ltd1 个研究点 分布在 1 个国家目标入组 479 人开始时间: 2022年5月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 479
- 试验地点
- 1
- 主要终点
- Percentage Change in Lumbar Spine BMD (Bone Mineral Density)
研究概览
简要总结
This is a randomized, double-blind, multicenter, parallel-arm, Phase 3 study to compare the efficacy, PK (Pharmacokinetic), PD (Pharmacodynamic), safety, and immunogenicity of Bmab 1000 and Prolia® in postmenopausal women with osteoporosis
详细描述
The study will consist of 3 study periods: Screening period; Part 1, double-blind active-controlled period; and Part 2, transition period. In the double-blind active-controlled period, eligible Patients will be randomized in a 1:1 ratio to receive either Bmab 1000 or Prolia®. Prior to dosing At Week 52, patients in Prolia® treatment group will be randomized again in a 1:1 ratio to either continue on Prolia® or be transitioned to Bmab 1000. To maintain the study blinding, the patients in the original Bmab 1000 arm will also go through the re-randomization procedure; however, they will continue to receive Bmab 1000. The interventions (Bmab 1000 or Prolia®) will be administered subcutaneously every 6 months. End-of-study visit will be at Week 78 post randomization (Month 18).
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)
盲法说明
Double-blind (Patient, Investigator)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women, aged ≥55 and <80 years at screening. Postmenopausal is defined as 12 months of spontaneous amenorrhea with serum FSH (follicle-stimulating hormone) levels ≥40 mIU/mL at screening or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- •Evidence of osteoporosis as assessed by lumbar spine (L1-L4) absolute BMD corresponding to a T-score classification ≤-2.5 and ≥-4.
- •At least 3 vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA at screening.
- •Patients with body weight ≥50 to <90 kg at screening.
排除标准
- •Patients with T-score of <-4.0 at the lumbar spine, total hip, or femoral neck.
- •Known history of previous exposure to denosumab (Prolia®, Xgeva®, or any biosimilar denosumab).
- •For prior or ongoing use of any osteoporosis treatment (other than calcium and vitamin D supplements) following points to be considered for the washout periods prior to the screening visit:
- •a. Oral bisphosphonate i. Ineligible if used for 3 or more years cumulatively ii. If used for <3 years, a gap of at least 1 year since the last dose is required at the screening visit b. Dose received any time
- •Systemic glucocorticosteroids
- •Patients with ongoing serious infections
- •Evidence of any of the following per the patient's history, DXA, or X-ray review and/or current disease:
- •Patient in bed rest for 2 or more weeks during the last 3 months prior to screening
- •Current hyperthyroidism or hypothyroidism
- •History and/or current hyperparathyroidism or hypoparathyroidism
- •Current hypocalcemia or hypercalcemia based on albumin-adjusted serum calcium
- •Any bone disease including bone metastasis or metabolic disease (except for osteoporosis), eg, osteomalacia or osteogenesis imperfecta, rheumatoid arthritis, Paget's disease, ALP (alkaline phosphatase) elevation (at investigator's discretion), Cushing's disease, clinically significant hyperprolactinemia (at investigator's discretion), fibrous dysplasia, malabsorption syndrome which may interfere with the interpretation of the results
- •History and/or presence of one severe or 3 or more moderate vertebral fractures
- •History and/or presence of hip fracture or bilateral hip replacement
- •Presence of an active healing fracture according to assessment of investigator
- •History of severe skeletal pain with bisphosphonates which, as per the investigator, is a risk to her participation in the trial
- •Oral/dental or periodontal conditions:
研究组 & 干预措施
Bmab 1000
Experimental
干预措施: Bmab 1000 (Biological)
Prolia®:
Active Comparator
干预措施: Prolia® (Biological)
结局指标
主要结局
Percentage Change in Lumbar Spine BMD (Bone Mineral Density)
时间窗: Baseline and Week 52
To demonstrate equivalent efficacy between Bmab 1000 and Prolia® based on percentage change from baseline at Week 52 in lumbar spine BMD
次要结局
- AUEC (Area Under the Effect Curve) of the Bone Resorption Marker sCTX (Serum C-terminal Telopeptide of Type 1 Collagen)(Baseline to Week 26)
- Percentage Change in Lumbar Spine BMD(Baseline and Week 26)
- Percentage Change in Total Hip BMD by DXA (Dual-energy X-ray Absorptiometry)(Week 52)
- Serum Concentrations of P1NP (Procollagen Type 1 N-terminal Propeptide)(Baseline up to Week 52)
- Incidence of TEAEs (Treatment-emergent Adverse Events) up to 6 Months After the Second Dose(Baseline up to Week 78)
- Incidence of ADA (Anti-drug Antibody)(Baseline up to Week 52 (Double-blind Active-controlled Period))
- Incidence of NAb (Neutralizing Antibody) up to Week 52(Week 78 (Transition Period))
- Percentage Change From Baseline in Hip BMD(Week 78)
- Percentage Change From Baseline in Femoral BMD(Week 52)
- Minimum Concentration (Cmin) of sCTX(baseline to Week 26)
- Denosumab Concentrations at Weeks 26(Weeks 26)
- Denosumab Concentrations at Weeks 52(Weeks 52)
- Denosumab Concentrations at Weeks 78(Weeks 78)
研究者
研究点 (1)
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