NCT04638543已完成2 期
A Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled, Multicenter, Phase 2a Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 Monotherapy in Patients With Gout or Hyperuricemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Mean percentage change in serum uric acid (sUA) levels
研究概览
简要总结
This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy, safety, and pharmacokinetics study of 6 different dose regimens of ABP-671 compared with placebo. The study will consist of three sequential groups with escalating total daily ABP-671 doses. Each group is further divided into two dose cohorts with either QD or BID dosing. Each dose group will have 3 stages following screening: Run-in, Dose Evaluation, and Follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able to understand the study procedures, the risks involved and willing to provide written informed consent before the first study related activity.
- •Subject meets the diagnosis of gout as per the American College of Rheumatism/ European League Against Rheumatism (EULAR) Gout Classification Criteria or diagnosis of hyperuricemia.
- •Subject has an sUA level ≥ 7.0 mg/dL at baseline.
- •Subject must be willing to discontinue any other UA-lowering medication (e.g., allopurinol, febuxostat, and probenecid) and take gout prophylaxis medication during the study.
- •Body mass index (BMI) ≤ 40 kg/m2.
排除标准
- •Subject with a documented history of rheumatoid arthritis or other autoimmune disease.
- •Subject with any clinically significant hepatic, cardiovascular, renal, neoplastic, psychiatric illness, or hematological disorders such as polycythemia vera, sickle cell disease, or myelodysplastic disorder.
- •Subject with a history of alcohol or drug abuse within the past 1 year prior to screening, or current evidence of substance dependence or abuse.
- •Subject with a positive test for active hepatitis B, hepatitis C infection or human immunodeficiency virus (HIV) infection.
- •Subject with active liver disease, or hepatic dysfunction.
- •Subject with an inadequate renal function with estimated serum creatinine > 1.5 mg/dL (> 0.133 mmol/L) or creatinine clearance < 60 mL/min (by Cockcroft-Gault formula).
- •Subject with a history of malignancy within the previous 5 years with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer.
- •Subject with unstable angina, New York Heart Association class III or IV heart failure, myocardial infarction, stroke, or deep venous thrombosis within the last 12 months; or subjects currently receiving anticoagulants.
- •Subject with QT interval corrected for heart rate according to Fridericia's formula > 470 msec (females) and > 450 msec (males) during the Screening Period, confirmed by a repeat assessment.
- •Subject with uncontrolled hypertension
- •Subject receiving chronic treatment with more than 325 mg aspirin per day.
- •Subject that requires or may require systemic immunosuppressive or immunomodulatory treatment.
- •Subject who received any investigational therapy within 30 days or 5 half-lives (whichever is longer) prior to screening.
- •Subject who is pregnant or breastfeeding.
研究组 & 干预措施
ABP-671
Experimental
The study will consist of three sequential groups with escalating total daily ABP-671 doses. Each group is further divided into two dose cohorts with either QD or BID dosing.
干预措施: ABP-671 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Mean percentage change in serum uric acid (sUA) levels
时间窗: Baseline to the end of the 4-week Dose Evaluation Period
次要结局
- Change in mean sUA(Baseline to the end of the 4-week Dose Evaluation Period)
- Mean percentage change and change in mean sUA between cohorts(Baseline to the end of the 4-week Dose Evaluation Period)
- Percentage of patients achieving sUA of < 6.0 mg/dL (0.357 mmol/L), < 5.0 mg/dL (0.297 mmol/L), and < 4.0 mg/dL (0.238 mmol/L)(Baseline to the end of the 4-week Dose Evaluation Period)
- Change in mean sUA compared between BID and QD dosing(Baseline to the end of the 4-week Dose Evaluation Period)
研究者
研究点 (5)
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