A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Patients Refractory to Conventional Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 41
- 主要终点
- Number of Participants With Serum Uric Acid (SUA) Reduction of < 6 mg/dL for at Least 80% of the Time
研究概览
简要总结
This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA®. Participants will be randomized 1:1 to receive treatment with SEL-212 or KRYSTEXXA® for 6 months. Efficacy assessments, as measured by serum uric acid (SUA) levels, will be conducted at intervals that are appropriate to determine treatment effect differences. Safety will be monitored throughout the study.
详细描述
This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA®. Participants will be randomized 1:1 to receive treatment with SEL-212 [a combination of pegadricase (SEL-037) and ImmTOR (SEL-110)] or KRYSTEXXA® for 6 months.
Study participants in the SEL-212 arm will receive study drug every 28 days for a total of up to 6 infusions of SEL-212. Study participants in the KRYSTEXXA® arm will receive study drug according to the manufacturer's prescribing information, i.e., every 14 days for a total of up to 12 infusions of KRYSTEXXA®.
Efficacy assessments, as measured by SUA levels, will be conducted at intervals that are appropriate to determine treatment effect differences. Safety will be monitored throughout the study.
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
- None
盲法说明
Assessments of qualitative endpoints will be conducted on an assessor-blinded basis.
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of symptomatic gout defined as:
- •≥ 3 gout flares within 18 months of Screening or
- •Presence of ≥ 1 tophus or
- •Current diagnosis of gouty arthritis
- •At the Screening Visit: male age 21 - 80 years, inclusive, or female of non-childbearing potential age 21-80 years, inclusive, where non-childbearing potential is defined as:
- •> 6 weeks after hysterectomy with or without surgical bilateral salpingooperhectony or
- •Post-menopausal (> 24 months of natural amenorrhea)
- •Has at the Screening Visit SUA ≥ 7 mg/dL, with chronic refractory gout defined as having failed to normalize SUA and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the medically appropriate dose or for whom these drugs are contraindicated;
- •Willing to provide written informed consent prior to the conduct of any study specific procedures;
- •Understands and is willing and able to comply with study requirements, including the schedule of follow-up visits
排除标准
- •Prior exposure to any experimental or marketed uricase (e.g., pegloticase [Krystexxa®], pegadricase [SEL-037], rasburicase [Elitek, Fasturtec]);
- •History of anaphylaxis or severe allergic reactions to medications;
- •History of any allergy to pegylated products
- •Drugs known to interact with Rapamune cannot be used during the trial;
- •Uncontrolled diabetes;
- •Glucose-6-phosphate dehydrogenase (G6PD) deficiency;
- •Uncontrolled hypertension;
- •Participants whose arrhythmia is unstable on current treatment;
- •History of coronary artery disease, including myocardial infarction or unstable angina, within the last 6 months;
- •Congestive heart failure;
- •History of hematological disorders within 1 year or autoimmune disorders, is immunosuppressed or immunocompromised;
- •Has received an inactivated vaccine in the previous 3 months or has received a live virus vaccine in the previous 6 months;
- •Is planning to receive any vaccination or live virus vaccination during the study;
研究组 & 干预措施
SEL-212
Intravenous (IV) infusion of SEL-212 every 28 days for up to 6 infusions
干预措施: SEL-212 (Drug)
KRYSTEXXA
IV infusion of KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 12 infusions
干预措施: KRYSTEXXA® (Drug)
结局指标
主要结局
Number of Participants With Serum Uric Acid (SUA) Reduction of < 6 mg/dL for at Least 80% of the Time
时间窗: Up to Month 6
The average of the data collected during Month 3 and Month 6 was reported.
次要结局
- Number of Participants With SUA Reduction of < 6 mg/dL for At Least 80% of the Time During Month 6(Month 6)
- Number of Participants With SUA Reduction of < 6 mg/dL for 100% of the Time During Month 6(Month 6)
- Quality of Life (QoL) as Assessed by Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scale(Baseline to End of Month 3, Baseline to End of Month 6)
- QoL as Assessed by Change From Baseline in Provider Global Assessment of Disease Activity (PrGA) Scale(Baseline to End of Month 3, Baseline to End of Month 6)
- QoL as Assessed by Change From Baseline in Short Form Health Survey 36 (SF-36) Scale(Baseline to End of Month 3, Baseline to End of Month 6)
- Number of Participants With Gout Flares Per 3-Month Period(Month 1 to Month 3, Month 4 to Month 6)
- Number of Gout Flares Per 3-Month Period(Month 1 to Month 3, Month 4 to Month 6)
- Change From Baseline in Number of Tender Joints(Baseline to End of Month 6)
- Change From Baseline in Number of Swollen Joints(Baseline to End of Month 6)