77242113PSO3006: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Ustekinumab Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ 77242113 for the Treatment of Participants With Moderate to Severe Plaque Ps
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 752
- 试验地点
- 162
- 主要终点
- JNJ-77242113 and Placebo Group: Percentage of Participants with Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater than or Equal to (>=) 2 Grade Improvement from Baseline at Week 16
研究概览
简要总结
The main purpose of this study is to assess how well JNJ-77242113 works when compared to placebo and ustekinumab in participants with moderate to severe plaque psoriasis.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), 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
排除标准
- •Nonplaque form of psoriasis (for example [e.g.], erythrodermic, guttate, or pustular)
- •Current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- •Known allergies, hypersensitivity, or intolerance to JNJ-77242113, ustekinumab, or its excipients
- •Major surgical procedure 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
- •Transplanted organ (with exception of a corneal transplant greater than [>] 12 weeks before the first administration of study intervention)
研究组 & 干预措施
Arm 3: Ustekinumab
Participants will receive Ustekinumab at Week 0, Week 4, and Week 16 followed by JNJ-77242113 once daily from Week 28 through Week 104. Participants will receive both Ustekinumab and placebo for JNJ-77242113 to maintain the blind through Week 28.
干预措施: Ustekinumab (Drug)
Arm 1: JNJ 77242113
Participants will receive JNJ-77242113 once daily from Week 0 through Week 104. All participant will receive ustekinumab matching placebo at Week 0, 4 and 16 to maintain the blind.
干预措施: JNJ-77242113 (Drug)
Arm 1: JNJ 77242113
Participants will receive JNJ-77242113 once daily from Week 0 through Week 104. All participant will receive ustekinumab matching placebo at Week 0, 4 and 16 to maintain the blind.
干预措施: Matching Placebo to Ustekinumab (Drug)
Arm 2: Placebo
Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for ustekinumab at Week 0, 4 and 16 and JNJ-77242113 from Week 16 through Week 104.
干预措施: Matching Placebo to JNJ-77242113 (Drug)
Arm 3: Ustekinumab
Participants will receive Ustekinumab at Week 0, Week 4, and Week 16 followed by JNJ-77242113 once daily from Week 28 through Week 104. Participants will receive both Ustekinumab and placebo for JNJ-77242113 to maintain the blind through Week 28.
干预措施: JNJ-77242113 (Drug)
Arm 2: Placebo
Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for ustekinumab at Week 0, 4 and 16 and JNJ-77242113 from Week 16 through Week 104.
干预措施: Matching Placebo to Ustekinumab (Drug)
Arm 3: Ustekinumab
Participants will receive Ustekinumab at Week 0, Week 4, and Week 16 followed by JNJ-77242113 once daily from Week 28 through Week 104. Participants will receive both Ustekinumab and placebo for JNJ-77242113 to maintain the blind through Week 28.
干预措施: Matching Placebo to JNJ-77242113 (Drug)
Arm 2: Placebo
Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for ustekinumab at Week 0, 4 and 16 and JNJ-77242113 from Week 16 through Week 104.
干预措施: JNJ-77242113 (Drug)
结局指标
主要结局
JNJ-77242113 and Placebo Group: Percentage of Participants with Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater than or Equal to (>=) 2 Grade Improvement from Baseline at Week 16
时间窗: Week 16
IGA score is given based on the investigator's assessment of the participant's plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's plaque psoriasis is assessed as: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
时间窗: Week 16
PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants achieving at least a 90 percent improvement from baseline in the PASI score.
次要结局
- JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 75 Response at Week 16(Week 16)
- JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 100 Response at Week 16(Week 16)
- JNJ-77242113 and Placebo Group: Percentage of Participants with IGA Score of 0 at Week 16(Week 16)
- JNJ-77242113 and Ustekinumab Group: Percentage of Participants with IGA Score of 0 at Week 28(Week 28)
- JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 90 Response at Week 28(Week 28)
- JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 100 Response at Week 28(Week 28)
- JNJ-77242113 and Placebo Group: Percentage of Participants with PSSD Symptom Score of 0 at Week 16(Week 16)
- JNJ-77242113 and Placebo Group: Percentage of Participants with >= 4 Point Improvement from Baseline in PSSD Itch Score at Week 16(Week 16)
- Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Week 108)
- JNJ-77242113 and Placebo Group: Percentage of Participants with PSSD Sign Score of 0 at Week 16(Week 16)
- JNJ-77242113 and Placebo Group: Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16(Baseline up to Week 16)
- JNJ-77242113 and Placebo Group: Percentage of Participants with DLQI Score of 0 or 1 at Week 16(Week 16)
- JNJ-77242113 and Placebo Group: Change from Baseline in Body Surface Area (BSA) Score at Week 16(Baseline up to Week 16)
- JNJ-77242113 and Ustekinumab Group: Percentage of Participants with >= 4 Point Improvement from Baseline in PSSD Itch Score at Week 28(Week 28)
- JNJ-77242113 and Ustekinumab Group: Change from Baseline in PSSD Sign Score at Week 28(Baseline up to Week 28)
- JNJ-77242113 and Ustekinumab Group: Change from Baseline in PSSD Symptom Score at Week 28(Baseline up to Week 28)
- JNJ-77242113 and Ustekinumab Group: Percentage of Participants with PSSD Sign Score of 0 at Week 28(Week 28)
- JNJ-77242113 and Ustekinumab Group: Percentage of Participants with PSSD Symptom Score of 0 at Week 28(Week 28)
- JNJ-77242113 and Ustekinumab Group: Change from Baseline in DLQI Score at Week 28(Baseline up to Week 28)
- JNJ-77242113 and Ustekinumab Group: Percentage of Participants with DLQI Score of 0 or 1 at Week 28(Week 28)
- JNJ-77242113 and Ustekinumab Group: Change from Baseline in BSA Score at Week 16(Baseline up to Week 16)
- JNJ-77242113 and Ustekinumab Group: Percentage of Participants with IGA Score of 0 at Week 16(Week 16)
- JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 90 Response at Week 16(Week 16)
- JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 100 Response at Week 16(Week 16)