CTIS2023-508424-34-00进行中（未招募）1 期
A Phase 3b, Randomized, Double-blind, Parallel Group, Multicenter Study to Evaluate Further Therapeutic Strategies with Guselkumab in Patients with Moderate-to-Severe Plaque-Type Psoriasis - CNTO1959PSO3012
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 828
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Male or female with at least 18 years of age., 2. Has a disease duration of plaque psoriasis of either =2 years or >2 years calculated from date at which first symptoms [plaque] were reported by subject to date of screening visit at screening; approximately 40% subjects must have a disease duration =2 years., 3. Has moderate-to-severe plaque-psoriasis defined by a) a PASI score >10 or affected BSA >10% and b) a DLQI score >10 at baseline (week 0)., 4. Is a candidate for systemic treatment for psoriasis., 5. Before first administration of study drug, a woman must be: a. Not of childbearing potential b. Of childbearing potential and practicing a highly effective method of contraception
排除标准
- •1. clinical active psoriasis arthritis which needs systemic therapy beyond NSAIDs, 2. diagnosed or reported history or current signs or symptoms indicating severe, progressive, or uncontrolled hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, which are detected at screening assessments, 3. unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within the last 3 months, diagnosed or reported by the subject, 4. Has a transplanted organ, 5. history of an infected joint prosthesis or has received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced
研究者
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