A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab in Improving the Signs and Symptoms and Inhibiting Radiographic Progression in 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
- 1,054
- 试验地点
- 506
- 主要终点
- Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of guselkumab treatment 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 active psoriatic arthritis (PsA) despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
- •Have a diagnosis of PsA for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening
- •Have active PsA as defined by: at least 3 swollen joints and 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligrams per deciliter (mg/dL) at screening from the central laboratory
- •Have >= 2 joints with erosions on baseline radiographs of the hands and feet as determined by central read
- •Have at least one of the following 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 centimeter (cm) diameter or nail changes consistent with psoriasis
排除标准
- •Has known allergies, hypersensitivity, or intolerance to study intervention or its excipients
- •Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (AS)/non-radiographic axial spondyloarthritis (nr-axSpA), systemic lupus erythematosus, or Lyme disease
- •Has previously received any biologic treatment
- •Has ever received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other Janus kinase (JAK) inhibitor
- •Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention
研究组 & 干预措施
Group 2: Guselkumab
Participants will receive guselkumab SC. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.
干预措施: Guselkumab (Drug)
Group 1: Guselkumab and Placebo
Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind. Participants who have not discontinued will be eligible to enter a long-term extension (LTE) and will receive guselkumab and placebo SC. After the study is unblinded to the investigative sites, participants will receive guselkumab and no longer be required to dose with placebo to maintain the blind.
干预措施: Guselkumab (Drug)
Group 1: Guselkumab and Placebo
Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind. Participants who have not discontinued will be eligible to enter a long-term extension (LTE) and will receive guselkumab and placebo SC. After the study is unblinded to the investigative sites, participants will receive guselkumab and no longer be required to dose with placebo to maintain the blind.
干预措施: Placebo (Drug)
Group 3: Placebo Followed by Guselkumab
Participants will receive placebo SC and will cross over to receive SC guselkumab. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.
干预措施: Guselkumab (Drug)
Group 3: Placebo Followed by Guselkumab
Participants will receive placebo SC and will cross over to receive SC guselkumab. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
时间窗: At Week 24
ACR 20 response: \>=20% improvement from baseline (bl) in both swollen (66 joints), tender (68 joints) joint count, \>=20% improvement from bl in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100mm, 0=no pain, 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100mm, 0=excellent, 100=poor), physician's global assessment of disease activity (VAS; 0-100mm, 0=no arthritis activity,100=extremely active arthritis), HAQ-DI (questionnaire assessing 8 functional areas; 0-3, 0=no difficulty, 3=inability to perform task in area), and CRP. Natural Disaster (ND)-site inaccessible due to COVID-19. Major Disruption (MD)-disruption involving Ukraine and neighboring countries/territories. Intercurrent event (ICE) handling: Composite-discontinue study drug not due to ND/MD, initiate/increase DMARD/oral corticosteroid, initiate prohibited PsA treatment; Hypothetical-discontinue/severe noncompliance of study drug due to ND/MD.
次要结局
- Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at Week 24(Baseline (after first administration of study drug) and Week 24)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(From baseline (after first administration of study drug) up to 168 weeks)
- Number of Participants With Serious Adverse Events (SAEs)(From baseline (after first administration of study drug) up to 168 weeks)
- Number of Participants With Reasonably Related Adverse Events (AEs)(From baseline (after first administration of study drug) up to 168 weeks)
- Number of Participants With TEAEs Leading to Discontinuation of Study Intervention(From baseline (after first administration of study drug) up to 168 weeks)
- Number of Participants With Treatment Emergent Infections(From baseline (after first administration of study drug) up to 168 weeks)
- Number of Participants With Injection-site Reactions Leading to Discontinuation of Study Intervention(From baseline (after first administration of study drug) up to 168 weeks)
- Number of Participants With Clinical Laboratory Abnormalities(From baseline (after first administration of study drug) up to 168 weeks)
- Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Toxicity Grade Laboratory Values(From baseline (after first administration of study drug) up to 168 weeks)
- Serum Guselkumab Concentration(From baseline (after first administration of study drug) up to 168 weeks)
- Number of Participants With Anti-guselkumab Antibodies(From baseline (after first administration of study drug) up to 168 weeks)