A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-88545223 For the Treatment of Participants With Active Psoriatic Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 75
- 主要终点
- Proportion of Participants who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16
研究概览
简要总结
The purpose of this study is to evaluate how well the study drug JNJ-88545223 works compared with a placebo (an inactive substance) in adults with active psoriatic arthritis (PsA). The study aims to see whether treatment with JNJ-88545223 can help reduce the signs and symptoms of PsA and improve joint and skin health.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for Psoriatic Arthritis (CASPAR) at screening
- •Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tender joints at screening and at baseline (Week 0/Day 1) based on the 66/68 joint assessment; AND (b) C-reactive protein (CRP) greater than or equal to (>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory
- •Have >= 1 of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
- •Have active plaque psoriasis with at least one psoriatic plaque of >= 2 centimeter (cm) diameter or nail changes consistent with psoriasis
- •A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention
排除标准
- •Has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
- •Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (except PsA), psychiatric, genitourinary, or metabolic disturbances
- •Has suspected or known allergies, hypersensitivity, or intolerance to JNJ-88545223 or excipients used in the investigational medicinal product (IMP), including placebo (JNJ-88545223 investigator's brochure); or has a history of severe allergic reaction, angioedema, or anaphylaxis to drugs or food
- •Has fibromyalgia or osteoarthritis symptoms that, in the opinion of the investigator, would have potential to interfere with efficacy assessments
- •Currently has a malignancy or has a history of malignancy within 5 years prior to screening
研究组 & 干预措施
Arm 2: JNJ-88545223 Dose 1
Participants will receive JNJ-88545223 Dose 1 from Week 0 to Week 16.
干预措施: JNJ-88545223 (Drug)
Arm 1: Placebo
Participants will receive matching placebo to JNJ-88545223, from Week 0 to Week 16.
干预措施: Placebo (Drug)
Arm 4: JNJ-88545223 Dose 3
Participants will receive JNJ-88545223 Dose 3 from Week 0 to Week 16.
干预措施: JNJ-88545223 (Drug)
Arm 3: JNJ-88545223 Dose 2
Participants will receive JNJ-88545223 Dose 2 from Week 0 to Week 16.
干预措施: JNJ-88545223 (Drug)
结局指标
主要结局
Proportion of Participants who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16
时间窗: Week 16
The ACR 50 responders are participants with an improvement of greater than or equal to (\>=) 50 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale \[VAS\], patient's global assessment of disease activity \[arthritis, VAS\] scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).
次要结局
- Proportion of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 16 Among Participants with Baseline Body Surface Area (BSA) Greater Than or Equal to (>=) 3 Percent (%) and With Baseline IGA Score of >=2(Week 16)
- Proportion of Participants Who Achieved PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2(Week 16)
- Proportion of Participants Who Achieved PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2(Week 16)
- Proportion of Participants who Achieved an ACR 20 Response at Week 16(Week 16)
- Proportion of Participants who Achieved an ACR 70 Response at Week 16(Week 16)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16(Baseline up to Week 16)
- Change From Baseline in 36 Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16(Baseline up to Week 16)
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Week 16)
- Number of Participants With Change from Baseline in the Laboratory Parameters(Baseline up to Week 16)