NCT03818607已完成3 期
A Randomized, Double-Blind, Active-Controlled Phase 3 Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)
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
- Amgen
- 入组人数
- 42
- 试验地点
- 24
- 主要终点
- LDH Level at Week 27 (Parallel Comparison)
研究概览
简要总结
This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥ 18 years of age.
- •Historical diagnosis of PNH.
- •Administration of eculizumab for ≥ 6 months and currently receiving 900 mg of eculizumab.
- •Hemoglobin ≥ 9.0 g/dL for at least 6 weeks before randomization.
- •Lactate dehydrogenase < 1.5 × the upper limit of normal at screening.
- •Platelet count ≥ 50 × 10^9/L.
- •Absolute neutrophil count (ANC) ≥ 0.5 x 10^9/L (500/μL).
- •Participants must be vaccinated against Neisseria meningitidis.
- •Participants must sign an IRB/IEC-approved ICF before participation in any procedures.
排除标准
- •Known or suspected hereditary complement deficiency.
- •Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure [New York Heart Association ≥ Class III], serious uncontrolled cardiac arrhythmia), peripheral vascular disease, cerebrovascular accident, or transient ischemic attack in the previous 6 months.
- •Evidence of acute thrombosis (liver Doppler ultrasound of hepatic and portal veins).
- •Known to be positive for human immunodeficiency virus.
- •Woman who is pregnant or breastfeeding.
- •Participant is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or participant is receiving other investigational agent(s).
- •Participant has known sensitivity to any of the products to be administered during the study, including mammalian cell-derived drug products.
- •History of meningococcal infection.
- •Presence or suspicion of active bacterial infection, or recurrent bacterial infection.
- •History of bone marrow transplantation.
- •Red blood cell transfusion required within 12 weeks before randomization.
- •Participant experienced ≥ 2 breakthrough events, (ie, signs and symptoms of intravascular hemolysis, that require dose and/or schedule adjustments of eculizumab) in the previous 12 months before screening.
研究组 & 干预措施
R (eculizumab) / T (ABP 959)
Other
Eculizumab for 52 weeks in Period 1 followed by ABP 959 for 26 weeks in Period 2
干预措施: ABP 959 (Drug)
T (ABP 959) / R (eculizumab)
Other
ABP 959 for 52 weeks in Period 1 followed by eculizumab for 26 weeks in Period 2
干预措施: ABP 959 (Drug)
T (ABP 959) / R (eculizumab)
Other
ABP 959 for 52 weeks in Period 1 followed by eculizumab for 26 weeks in Period 2
干预措施: Eculizumab (Drug)
R (eculizumab) / T (ABP 959)
Other
Eculizumab for 52 weeks in Period 1 followed by ABP 959 for 26 weeks in Period 2
干预措施: Eculizumab (Drug)
结局指标
主要结局
LDH Level at Week 27 (Parallel Comparison)
时间窗: Week 27
The primary analysis for the parallel comparison was hemolysis as measured by LDH at Week 27 by initial treatment received (Period 1).
Time-adjusted Area Under the Effect Curve (AUEC) of LDH (Crossover Comparison Per Assigned Treatment)
时间窗: From Week 13 to Week 27, from Week 39 to Week 53, and from Week 65 to Week 79
The primary analysis for the crossover comparison was hemolysis, as measured by the time-adjusted AUEC of LDH, according to treatment assigned during each of the 14-week assessments during Periods 1 and 2.
次要结局
- Mean Total Complement (50% Total Hemolytic Complement Activity [CH50])(Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79)
- Total and Unbound Pharmacokinetics (PK) Area Under the Curve (AUC) of ABP 959 and Eculizumab From Week 13 to Week 15 (Period 1)(PK samples were collected predose and immediately postdose Week 13, 7 days post the Week 13 dose (Week 14), and predose at Week 15)
- Mean LDH Levels by Visit up to Week 79(Baseline, Week 3, Week 7, Week 13, Week 15, Week 19, Week 25, Week 27, Week 29, Week 33, Week 39, Week 41, Week 43, Week 45, Week 47, Week 49, Week 51, Week 53, Week 55, Week 59, Week 65, Week 67, Week 69, Week 71, Week 73, Week 75, Week 77, and Week 79)
- Mean Number of Packed RBC Units Transfused Per Month(Baseline to End of Study (up to Week 79))
- Degree of Hemoglobinuria(Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79)
- Mean Haptoglobin Levels(Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79)
- Mean Bilirubin Levels(Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79)
- Mean Total Hemoglobin Levels(Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79)
- Mean Serum-free Hemoglobin Levels(Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79)
- Mean Percentage of Type III Erythrocytes(Baseline, Week 27, Week 39, Week 53, Week 65 and Week 79)
- LDH Levels at Week 53 and Week 79(Week 53 (first week of Period 2) and Week 79 (last week of Period 2))
- Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab(PK samples were collected predose at the prespecified timepoints: baseline, Week 3, Week 7, Week 13, Week 15, Week 19, Week 27, Week 33, Week 39, Week 45, Week 51, Week 53, Week 55, Week 59, Week 65, Week 71, Week 77, and Week 79)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Day 1 to End of Study (up to Week 79))
- Number of Participants With Antidrug Antibodies (ADAs)(Blood samples for ADA assessments were taken predose at baseline, Week 3, Week 7, Week 13, Week 19, Week 25, Week 27, Week 33, Week 39, Week 45, Week 51, Week 53, Week 55, Week 59, Week 65, Week 71, Week 77 and Week 79.)
研究者
研究点 (24)
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