A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-naïve Participants With Active Psoriatic Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 552
- 试验地点
- 155
- 主要终点
- Proportion of Participants who Achieve an American College of Rheumatology (ACR) ACR 20 Response at Week 16
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
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 (b) C-reactive protein (CRP) greater than or equal to (>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory
- •Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
- •Have active plaque psoriasis with at least one psoriatic plaque of >= 2 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 previously received any biologic disease-modifying antirheumatic drugs (DMARDs) for PsA or psoriasis
- •Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances
- •Has known allergies, hypersensitivity, or intolerance to icotrokinra or its excipients
- •Has other inflammatory diseases that might confound the evaluations of benefit of icotrokinra therapy, including but not limited to rheumatoid arthritis (RA), systemic lupus erythematosus, or lyme disease
- •Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator's opinion, would have potential to interfere with efficacy assessments
研究组 & 干预措施
Group III: Placebo
Participants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra dose 1 or dose 2. Participants who continue into the LTE will continue to receive icotrokinra dose 1 or dose 2.
干预措施: Placebo (Drug)
Group II: Icotrokinra Dose 2
Participants will receive icotrokinra dose 2. Participants who continue into a LTE will continue to receive icotrokinra dose 2.
干预措施: Icotrokinra (Drug)
Group I: Icotrokinra Dose 1
Participants will receive icotrokinra dose 1. Participants who continue into a long term extension (LTE) will continue to receive icotrokinra dose 1.
干预措施: Icotrokinra (Drug)
Group IV: Active Reference Comparator
Participants will receive active reference drug. Participants who continue into a LTE will cross-over to receive icotrokinra dose 1 or dose 2.
干预措施: Icotrokinra (Drug)
Group III: Placebo
Participants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra dose 1 or dose 2. Participants who continue into the LTE will continue to receive icotrokinra dose 1 or dose 2.
干预措施: Icotrokinra (Drug)
Group IV: Active Reference Comparator
Participants will receive active reference drug. Participants who continue into a LTE will cross-over to receive icotrokinra dose 1 or dose 2.
干预措施: Active reference comparator (Drug)
结局指标
主要结局
Proportion of Participants who Achieve an American College of Rheumatology (ACR) ACR 20 Response at Week 16
时间窗: Week 16
The ACR 20 responders are participants with an improvement of greater than or equal to (\>=) 20 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 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 Achieve Psoriatic Area and Severity Index (PASI) 75 Response at Week 16 Among Participants with Baseline Body Surface Area (BSA) Greater Than Equal to (>=) 3 Percent (%) and an IGA Score of >=2 at Baseline(Week 16)
- Proportion of Participants Who Achieve PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline(Week 16)
- Proportion of Participants Who Achieve PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline(Week 16)
- Proportion of Participants who Achieve an ACR 70 Response at Week 16(Week 16)
- Proportion of Participants with an Investigator Global Assessment (IGA) Psoriasis Score of 0 or 1 And >=2 Grade Improvement From Baseline at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline(Week 16)
- Proportion of Participants who Achieve an ACR 50 Response at Week 16(Week 16)
- Proportion of Participants who Achieve Minimal Disease Activity (MDA) at Week 16(Week 16)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16(From Baseline to Week 16)
- Changes From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16(From Baseline to Week 16)
- Proportion of Participants With Resolution of Enthesitis at Week 16 Among Those With Enthesitis at Baseline(Week 16)
- Proportion of Participants With Resolution of Dactylitis at Week 16 Among Those With Dactylitis at Baseline(Week 16)
- Change From Baseline in Enthesitis Score (LEI) at Week 16 in Participants With Enthesitis at Baseline(From Baseline to Week 16)
- Change From Baseline in Dactylitis Score at Week 16 in Participants With Dactylitis at Baseline(From Baseline to Week 16)
- Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16(From Baseline to Week 16)