A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Quarterly and Monthly TOUR006 in Participants With Chronic Kidney Disease and Elevated High-Sensitivity C-Reactive Protein
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 76
- 主要终点
- Evaluate the effects of TOUR006 compared with placebo on hs-CRP
研究概览
简要总结
This study will evaluate the safety, tolerability, pharmacokinetics, and CRP-lowering effect of quarterly and monthly subcutaneous administration of TOUR006 (also known as pacibekitug) in participants with chronic kidney disease and elevated hs-CRP.
详细描述
Previous clinical studies have suggested that IL-6-driven inflammation plays a key role in the pathogenesis of cardiovascular diseases including atherosclerotic cardiovascular disease (ASCVD) and heart failure. This Phase 2 study will evaluate the safety, tolerability, pharmacokinetics, and CRP-lowering effect of quarterly and monthly subcutaneous administration of TOUR006, a fully human monoclonal antibody against IL-6. TOUR006 binds the IL-6 cytokine and inhibits downstream IL-6 signaling, thereby reducing the pharmacodynamic marker, hs-CRP.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age ≥18 years at time of ICF signature.
- •Serum hs-CRP level ≥2.0 mg/L and <15 mg/L
- •Diagnosis of chronic kidney disease, eGFR ≥15 and <60 mL/min/1.73 m2 or eGFR ≥60 mL/min/1.73m2 and UPCR>200 mg/g
- •Received COVID-19 vaccine at least 30 days prior to the Screening visit, per participant verbal attestation.
- •Agreement to comply with contraception and reproduction restrictions
排除标准
- •Clinical evidence or suspicion of active infection
- •Current or recent COVID-19 infection within 30 days
- •Serious infection within 6 months or more than 1 such episode within 18 months
- •Any history of a serious opportunistic infection within 18 months
- •Known history of immunodeficiency
- •History of gastrointestinal ulceration or perforation within 12 months
- •History of active diverticulitis, active inflammatory bowel disease, or GI abscess within 12 months
- •History of GI bleeding requiring hospitalization and/or transfusion within 6 months
- •New York Heart Association Class III or IV congestive heart failure and/or hospitalization for heart failure exacerbation within 6 months
- •Acute coronary syndrome, stroke, transient ischemic attack, or other thrombotic or thromboembolic event, or arterial revascularization procedure within 6 months
研究组 & 干预措施
TOUR006 - 50 MG
50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
干预措施: TOUR006 - 50 MG (Drug)
TOUR006 - 25 MG
25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
干预措施: TOUR006 - 25 MG (Drug)
TOUR006 - 15 MG
15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
干预措施: TOUR006 - 15 MG (Drug)
Placebo
Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
干预措施: Placebo (Other)
结局指标
主要结局
Evaluate the effects of TOUR006 compared with placebo on hs-CRP
时间窗: 90 days
Evaluates the change from baseline in hs-CRP comparing TOUR006 and placebo
Time-Averaged Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Through Day 90
时间窗: Baseline through 90 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.
Time-averaged percent change from baseline in high-sensitivity C-reactive protein (hs-CRP) through Day 90. The time-averaged percent change from baseline in hs-CRP is the area under the curve for percent change from baseline in hs-CRP divided by the number of days from the observed Day 30 to Day 90 visits (approximately 60 days if visits occur according to the protocol). The calculation uses the linear trapezoidal rule according to the observed visit days.
次要结局
- Evaluate the effects of TOUR006 compared with placebo on hs-CRP(180 days)
- Evaluate the pharmacokinetics by measuring serum concentrations of TOUR006(Baseline through Day 365)
- Evaluate the safety and tolerability of TOUR006 in participants with elevated cardiovascular risk and CKD(365 days)
- Proportion of Participants With Time-averaged Hs-CRP < 2 mg/L (90 Days)(Baseline through 90 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.)
- Time-Averaged Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Through Day 180(Baseline through 180 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.)
- Evaluate the Pharmacokinetics by Measuring Serum Concentrations of TOUR006(Baseline through Day 365)
- Evaluate the Safety and Tolerability of TOUR006 in Participants With Elevated Cardiovascular Risk and CKD(Baseline through Day 365.)
- Evaluate the effects of TOUR006 compared with placebo on hs-CRP(90 days)