EUCTR2021-005987-23-FR进行中（未招募）1 期
A Phase 2a Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Oral Tablet Formulation of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 89
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. Participant is 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age, inclusive
- •2. Participant has a diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks prior to the first administration of study intervention
- •3. Participant has a total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline
- •4. Participant has a total Psoriasis area and severity index (PASI) >=12 at screening and baseline
- •5. Participant has a total Investigator Global Assessment (IGA) >=3 at screening and baseline
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1. Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
- •2. Participant has current drug-induced psoriasis (for example, a new calcium channel blockers, or lithium)
- •3. Participant have previously received any other therapeutic agent directly targeted to interleukin 23 (including but not limited to guselkumab, tildrakizumab, or risankizumab)
- •4. Participant has received any therapeutic agent directly targeted to interleukin 17 (IL-17), interleukin 17 receptor (IL-17R) or interleukin 12/23 (IL-12/23) (including but not limited to secukinumab, ixekizumab, brodalumab, or ustekinumab) or has received biological therapy targeting tumor necrosis factor (TNF) (including, but not limited to adalimumab, infliximab, or etanercept) within 12 weeks or 5 halflives, whichever is longer, of the first administration of study intervention
- •5. Participant has received proton pump inhibitors (including but not limited to omeprazole, esomeprazole, lansoprazole, rabeprazole, pantoprazole, dexlansoprazole, or Zegerid) within 1 week of first administration of study intervention
研究者
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