ISRCTN69978417进行中(未招募)3 期
A phase 3 multicentre, randomised, double-blind, placebo-controlled and deucravacitinib active comparator-controlled study to evaluate the efficacy and safety of JNJ-77242113 for the treatment of participants with moderate to severe plaque psoriasis - ICONIC-ADVANCE 1
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中(未招募)
- 入组人数
- 750
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
- 性别
- All
入选标准
- •1. Aged 18 years or older;
- •2. Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks before the first administration of study intervention
- •3. Total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline;
- •4. Total psoriasis area and severity index (PASI) >=12 at screening and baseline;
- •5. Total investigator global assessment (IGA) >=3 at screening and baseline;
- •6. Candidate for phototherapy or systemic treatment for plaque psoriasis.
排除标准
- •1. Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular);
- •2. Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium);
- •3. A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, haematologic, rheumatologic, psychiatric, or metabolic disturbances;
- •4. Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients;
- •5. Major surgical procedure, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study.
研究者
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