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
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 67
- 主要终点
- Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of an oral tablet formulation of JNJ-77242113 compared with placebo in participants with moderate-to-severe plaque psoriasis.
详细描述
The population of people living with moderate to severe psoriasis is approximately 3.5 billion who are mostly managed with topical and conventional therapies. JNJ-77242113, investigational drug, targets the immune responses in the body and skin which impacts diseases, such as psoriasis and psoriatic arthritis and this study evaluates JNJ-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. The hypothesis of this study is that an oral tablet formulation of JNJ-77242113 will result in superior efficacy compared with placebo as determined by the percentage of participants achieving Psoriasis Area and Severity Index (PASI) 75 (greater than or equal to [>=] 75 percentage [%] improvement in PASI) (PASI 75) response at Week 16. The total duration of this study is up to 24 weeks which includes a screening period of less than or equal to (<=) 4 weeks, a 16-week placebo- controlled treatment period, and a follow-up visit approximately 4 weeks after the last administration of study intervention. Safety assessments include adverse events (AEs) monitoring, clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs, physical examinations, concomitant medication monitoring, pregnancy testing, Columbia Suicide Severity Rating Scale (C-SSRS) and tuberculosis evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has a diagnosis of plaque psoriasis, with or without psoriatic arthritis, for at least 26 weeks prior to the first administration of study intervention
- •Participant has a total Body Surface Area (BSA) greater than or equal to (>=) 10 percentage (%) at screening and baseline
- •Participant has a total Psoriasis Area and Severity Index (PASI) >= 12 at screening and baseline
- •Participant has a total Investigator's Global Assessment (IGA) >= 3 at screening and baseline
- •Participant be a candidate for phototherapy or systemic treatment for plaque psoriasis
排除标准
- •Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
- •Participant has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- •Participant have previously received any other therapeutic agent directly targeted to interleukin 23 (including but not limited to guselkumab, tildrakizumab, or risankizumab)
- •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 half-lives, whichever is longer, of the first administration of study intervention
- •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
研究组 & 干预措施
Group 1: JNJ-77242113 Dose 1
Participants will receive JNJ-77242113 Dose 1 as delayed release tablets orally once daily from Week 0 through Week 16.
干预措施: JNJ-77242113 (Drug)
Group 2: JNJ-77242113 Dose 2
Participants will receive JNJ-77242113 Dose 2 as delayed release tablets orally once daily from Week 0 through Week 16.
干预措施: JNJ-77242113 (Drug)
Group 3: Placebo
Participants will receive oral dose of matching placebo once daily from Week 0 through Week 16.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16
时间窗: Week 16
Percentage of participants achieving PASI 75 score (greater than or equal to \[\>=\] 75 percentage \[%\] improvement from baseline in PASI) at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: head, trunk, upper, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
次要结局
- Number of Participants with Adverse Events (AEs)(Up to Week 24)
- Number of Participants with Serious Adverse Events (SAEs)(Up to Week 24)
- Change from Baseline in PASI Total Score at Week 16(Baseline and Week 16)
- Percentage of Participants Achieving PASI 90 Score at Week 16(Week 16)
- Percentage of Participants Achieving PASI 100 Score at Week 16(Week 16)
- Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16(Week 16)
- Percentage of Participants Achieving an IGA Score of Cleared (0) at Week 16(Week 16)
- Change from Baseline in Body Surface Area (BSA) at Week 16(Baseline and Week 16)