NCT07116967招募中3 期
A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants With Moderate-to-Severe Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 3,040
- 试验地点
- 744
- 主要终点
- Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization
研究概览
简要总结
A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
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
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with moderate-to-severe plaque psoriasis:
- •Deemed by the Investigator to be a candidate for phototherapy or systemic treatment for psoriasis, including ustekinumab;
- •Have at least 1 of the following cardiovascular risk factors:
- •Current cigarette smoker
- •Diagnosis of hypertension
- •Diagnosis of hyperlipidemia
- •Diabetes mellitus type 1 or 2
- •History of one or more of the following cardiovascular events: Coronary intervention (PCI) or coronary artery bypass grafting (CABG), myocardial infarction (heart attack), cardiac arrest, hospitalization for unstable angina, acute coronary syndrome, stroke, or transient ischemic attack
- •Family history of premature coronary heart disease or sudden death in a first-degree male relative younger than 55 years of age or in a first-degree female relative younger than 65 years of age.
排除标准
- •Participants must not have recent history of 1 of the following cardiovascular events: MI, stroke, or coronary revascularization, or VTE within 90 days prior to Day
- •Participants must not have unstable CVD, defined as a recent clinical cardiovascular event (eg, unstable angina, rapid atrial fibrillation), or a cardiac hospitalization (eg, pacemaker implantation, HF) within 90 days prior to Day
- •Participants must not have evidence of active cancer or history of cancer (solid organ or hematologic malignancy including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma, or carcinoma of cervix in situ that has been treated with no evidence of recurrence).
- •Other protocol define inclusion/exclusion criteria apply.
研究组 & 干预措施
Arm A
Experimental
干预措施: Deucravacitinib (Drug)
Arm B
Active Comparator
干预措施: Ustekinumab (Drug)
结局指标
主要结局
Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization
时间窗: Up to 5 years
MACE defined as non-fatal myocardial infarction \[MI\], nonfatal stroke, and cardiovascular death
次要结局
- Number of participants with composite venous thromboembolism (VTE)(Up to 5 years)
- Number of participants with heart failure (HF) requiring hospitalization or urgent visit(Up to 5 years)
- All-cause mortality(Up to 60 days after last dose)
- Death due to cardiovascular events(Up to 5 years)
- All-cause mortality(Up to 60 days after last dose)
- Number of participants with non-fatal MI(Up to 5 years)
- Number of participants with coronary revascularization(Up to 5 years)
- Number of participants with composite venous thromboembolism (VTE)(Up to 5 years)
- Number of participants with arterial thromboembolic events (including retinal artery occlusion)(Up to 5 years)
- Number of participants with heart failure (HF) requiring hospitalization or urgent visit(Up to 5 years)
- Number of participants with opportunistic infections(Up to 5 years)
- Number of participants with non-fatal stroke(Up to 5 years)
- Number of participants with pulmonary embolism (PE)(Up to 5 years)
- Number of participants with deep vein thrombosis (DVT)(Up to 5 years)
- Number of participants with Serious AEs (SAEs)(Up to 60 days after last dose)
- AEs leading to permanent treatment discontinuation(Up to 60 days after last dose)
- Change from baseline in liver function test(Up to 60 days after last dose)
- Change from baseline in fasting lipid panel(Up to 60 days after last dose)
- Number of participants with 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death)(Up to 5 years)
- Number of participants with Malignancy excluding non-melanoma skin cancer (NMSC)(Up to 5 years)
- Number of participants with NMSC(Up to 5 years)
研究者
研究点 (744)
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