JPRN-jRCT2031230434尚未招募3 期
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants with Moderate to Severe Plaque Psoriasis with Randomized Withdrawal and Retreatment - ICONIC-LEAD
akano Masayoshi0 个研究点目标入组 600 人开始时间: 2023年11月5日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
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
- >= 12age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Diagnosis of plaque psoriasis, with or without psoriatic arthritis, for at least 26 weeks prior to the first administration of study intervention
- •- Total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline
- •- Total psoriasis area and severity index (PASI) >=12 at screening and baseline
- •- Total investigator global assessment (IGA) >=3 at screening and baseline
- •- Candidate for phototherapy or systemic treatment for plaque psoriasis
- •- A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention
排除标准
- •- Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
- •- Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- •- A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- •- Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
- •- Major surgical procedures, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from a 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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