NCT04804111已完成2 期
A Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-finding Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of URC102 in Patient With Gout
JW Pharmaceutical2 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2019年1月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 2
- 主要终点
- Serum uric acid response rate (< 6.0 mg/dL) at week 4 after the IP administration.
研究概览
简要总结
To confirm the safety and efficacy (dose response and optimal dose according to the serum uric acid response rate) of URC102 when orally-administered to patients with gout and gout-related hyperuricemia in comparison with placebo.
Therapeutic dose-finding study, Placebo-controlled, randomized, double-blind, multicenter, phase 2 clinical trial.
详细描述
Placebo-controlled, randomized, double-blind, multicenter, phase 2 clinical trial.
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
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Screening Inclusion Criteria The subjects must meet all the following criteria to be eligible for articipation in this study.
- •Subjects who are aged ≥19 and <70 years at the time of providing written informed consent
- •Subjects who are diagnosed with gout according to American College of Rheumatology (1977) criteria for the classification of acute arthritis of primary gout.
- •Subjects who have the ability and willingness to actively conduct TLC recommended in this study
- •Subjects who provided written informed consent to voluntarily participate in the study
- •Randomization Inclusion Criterion. Subjects who meet the screening inclusion criteria will be randomly assigned to the following criteria.
- •sUA ≥ 7.0 mg/dL at Visit 2
排除标准
- •Subjects who have medical history or comorbidity as follow; (1) Active malignancy or history of malignancy within the past 5 years at the time of screening (2) Urolithiasis (3) Clinically important allergic disease (anaphylactic shock, etc.) (4) Lesch-Nyhan syndrome (5) Hereditary problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption (6) Ischemic heart diseases or congestive heart failure (7) Organ transplantation (recipient or scheduled to receipt)
- •Subjects who have comorbidity or abnormality of lab results as follows; (1) Uncontrolled diabetes mellitus with drug therapy
- •HbA1c ≥ 9% or
- •Fasting plasma glucose (FPG) ≥160 mg/dL (2) Uncontrolled hypertension with treatment
- •Systolic blood pressure (SBP) ≥180 mmHg or
- •Diastolic blood pressure (DBP) ≥ 110 mmHg (3) Uncontrolled dyslipidemia with treatment
- •Total cholesterol ≥ 250 mg/dL (at least 8 hours of fasting) (4) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 X upper limit of normal (ULN) or Total bilirubin ≥ 1.5 X ULN (5) eGFR* < 60 mL/min/1.73m2 * eGFR (MDRD equation) GFR(ml/min/1.73m2) = 186 × (SCr)-1.154 × (age)-0.203 × (0.742 if female) × (1.210 if African American) (6) Uncontrolled thyroid function with treatment (thyroid-stimulating hormone (TSH) ≥ 1.5 X UNL
- •Subjects who are judged by the investigator to have a clinical cardiovascular disease that may affect the study based on the 12-lead ECG obtained at screening or those suspected to be at such risk
- •Patients who have received or plan to receive any XOI or uricosuric agents within 3 weeks prior to study treatment
- •Patients who have received or plan to receive diuretics or any medication action on human Uric Acid Transporter 1(hURAT1) such as indomethacin, pyrazinamide, fenofibrate, atorvastatin, amlodipine, losartan, captopril, enalapril, salicylates etc. within 2 weeks prior to study treatment However, those who have been on stable doses as below are allowed to participate in the study, if the administration method and dosage remain the same during the study period (1) Diuretics (thiazide only or thiazide-based combination, etc.) and antihypertensive agents (losartan etc.) used for the treatment of hypertension (2) Fenofibrate or lipid lowering drugs (atorvastatin) used for hyperlipidemia (3) Salicylates (aspirin)
- •Patients who have been administered or plan to administer Mercaptopurine, Azathioprine, Theophyline within 1 week or within more than 5 times of its half-life prior to the Visit 1
- •HIV Ag/Ab, HBs Ag or HCV Ab positive at screening
- •Subjects who have known hypersensitivity or allergy to IPs (URC102 or febuxostat) or any components in their formulations
- •Subjects who have childbearing or nursing
- •Subjects who agree to use methods of birth control* during the study period and for up to 7 days after the final administration of the IP
- •* Methods of birth control: ① intrauterine device or birth control implant, ② dual protection (condom with spermicide and contraceptive diaphragm or contraceptive sponge or cervical cap ③ surgical sterilization (vasectomy or tubal ligation or etc.)
- •Subjects who have been administered any other IP or investigational device by participating in other studieswithin 4 weeks or within more than 5 times of its halflife prior to the Visit 1
- •Subjects who have a history of drug or alcohol abuse within 5 years prior to the Visit 1
- •Subjects who have any other reason that may affect the study or those who are judged by the investigator to be ineligible for participation in the study
研究组 & 干预措施
Febuxostat 80 mg
Other
maintain the initial dose, without increasing the dose.
干预措施: arm 4 (Drug)
Placebo
Placebo Comparator
maintain the initial dose, without increasing the dose.
干预措施: arm 0 (Drug)
URC102 3mg
Active Comparator
Administer 3 mg of URC102 for 12 weeks
干预措施: arm 1 (Drug)
URC102 6mg
Active Comparator
Administer 3 mg of URC102 for 1 week and 6 mg of URC102 for 11 Weeks.
干预措施: arm 2 (Drug)
URC102 9mg
Active Comparator
Administer 3 mg of URC102 for 1 week and 6 mg of URC102 for 1 Weeks, maintain 9 mg of URC102 dose
干预措施: arm 3 (Drug)
结局指标
主要结局
Serum uric acid response rate (< 6.0 mg/dL) at week 4 after the IP administration.
时间窗: Week 4
次要结局
- Serum uric acid response rate (< 5.0 mg/dL) at week 4 after the IP administration.(Week 4)
- Serum uric acid response rate(< 6.0 mg/dL) at week 8 and week 12 after the IP administration(Week 8, Week 12)
- serum uric acid response rate(< 5.0 mg/dL) at week 8 and week 12 after the IP administration(Week 8, Week 12)
- Percent Change in Serum Uric Acid from Baseline to week 4(Week 4)
- The Incidence rate of gout attack from baseline to week 4(week 4)
- Percent Change in Serum Uric Acid from Baseline to week 8 and week 12(Week 8, Week 12)
- The Incidence rate of gout attack from baseline to week 8 and 12(Week 8, Week 12)
- Change in Serum Uric Acid at week 4 from Baseline(Week 4)
- Change in Serum Uric Acid at week 8 and 12 from Baseline(Week 8, Week 12)
研究者
研究点 (2)
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