JPRN-jRCT2071230104尚未招募3 期
A Phase 3, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
akano Masayoshi0 个研究点目标入组 16 人开始时间: 2023年12月25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
- 16
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
- •The study participant has a diagnosis of generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP) at screening. For GPP, a diagnosis must be classified based on the criteria for diagnosis of GPP by the Japanese Dermatological Association (JDA); for EP, has a history of plaque-type psoriasis. In addition, has an involved body surface area (BSA) of lesion greater than or equal to (>=) 80 percent (%) at baseline
- •- Candidate for phototherapy or systemic treatment for psoriasis (either naive or history of previous treatment)
- •- A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and have a negative urine pregnancy test at Week 0 prior to administration of study intervention
- •- A male participant must agree not to plan to father a child while enrolled in this study or within 90 days after the last dose of study intervention
- •- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention
排除标准
- •- The study participant has a total score of JDA severity index for GPP >=14 at baseline if participants have a diagnosis of GPP
- •- The study participant has a differential diagnosis of the erythroderma (for example, erythroderma caused by lymphoma or drug eruption) other than EP
- •- The study participant has a history of or current diagnosis or signs or symptoms of severe, progressive, or uncontrolled liver, renal; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- •- The study participant has a history of amyloidosis
- •- Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
- •- The study participant who doesn't meet the criteria of prior/current concomitant therapy and/or history/conditions of infections
研究者
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