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临床试验/ISRCTN69978417
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

Janssen-Cilag International N.V.0 个研究点目标入组 750 人开始时间: 2023年12月8日最近更新:
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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