2023-503766-24-00招募中4 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 (PRAGMATYK)
Bristol-Myers Squibb Services Unlimited Company6 个研究点 分布在 2 个国家目标入组 22 人开始时间: 2026年1月19日最近更新:
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 6
- 主要终点
- Composite cardiovascular endpoint defined as: adjudicated 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death) plus coronary revascularization
研究概览
简要总结
Assess the cardiovascular safety of long-term use of deucravacitinib in comparison to ustekinumab in adults with moderate-to-severe plaque psoriasis
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adult participants aged 40 years or older (inclusive)
- •Participants with moderate-to-severe plaque psoriasis as defined by a PASI ≥ 12, BSA ≥ 10% and sPGA score ≥ 3 at the time of the Screening Visit and Day 1 visits
- •Participants who are candidates for phototherapy or systemic treatment of psoriasis
- •Eligible participants should have at least 1 of the following cardiovascular risk factors: Current cigarette smoker, Diagnosis of hypertension or use of blood pressure-lowering medications, Diagnosis of dyslipidemia, Diabetes mellitus type 1 or 2, History of 1 or more of the following CVD events: coronary revascularization procedures including PCI or CABG, MI, cardiac arrest, hospitalization for unstable angina, acute coronary syndrome, stroke, or transient ischemic attack, Obesity defined by a body mass index ≥ 30 kg/m2, Family history of premature coronary heart disease
排除标准
- •Recent history of 1 or more of the following cardiovascular events: MI, stroke, history of coronary revascularization, or VTE within 90 days prior to Day 1
- •Evidence of active cancer or a history of cancer or lymphoproliferative disease within the previous 5 years
研究组 & 干预措施
deucravacitinib
Experimental
Participants receiving deucravacitinib
干预措施: deucravacitinib (Drug)
结局指标
主要结局
Composite cardiovascular endpoint defined as: adjudicated 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death) plus coronary revascularization
Composite cardiovascular endpoint defined as: adjudicated 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death) plus coronary revascularization
次要结局
- Adjudicated events of: Non-fatal MI, non-fatal stroke, cardiovascular death, coronary revascularization, 3-point MACE (non-fatal MI, nonfatal stroke, and cardiovascular death), PE, DVT, the composite of all VTE events of PE, DVT and retinal vein occlusion, arterial thromboembolic events (including retinal artery occlusion), HF requiring hospitalization or urgent care visit, malignancy excluding NMSC, NMSC, and opportunistic infections including TB and complicated herpes zoster
- SAEs, all-cause mortality, and AEs leading to permanent treatment discontinuation
- Laboratory tests: complete metabolic panel, including liver function test and fasting lipid panel at baseline and every 26 weeks thereafter
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company
研究点 (6)
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