A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 872
- 主要终点
- Number of Visits at Which Participants Achieved an Investigator's Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash) who had inadequate response to ustekinumab.
详细描述
This is a randomized (assignment of study drug by chance), double-blind (participants nor study staff will know the identity of study drugs), multicenter study to evaluate efficacy and safety of guselkumab for the treatment of participants with moderate to severe plaque-type psoriasis who had an inadequate response to ustekinumab. The study will consist of a screening period, open-label and double-blind treatment periods, and a follow-up period. The treatment period will have 2 phases: an open-label treatment phase during which all participants will receive ustekinumab at Weeks 0 and 4 and a blinded treatment phase during which participants with an inadequate Investigator's Global Assessment response (IGA≥2) to ustekinumab at Week 16 will be randomized to receive either guselkumab or ustekinumab through Week 44. Participants with an IGA response of 0 or 1 (cleared or minimal disease) at Week 16 will continue to receive open-label treatment with ustekinumab every 12 weeks through Week 40. All participants will complete a follow-up phase through Week 52 for efficacy and through Week 60 for safety evaluations. The total duration of the study will be approximately 64 weeks (includes a 4-week screening period). Participants' safety will be monitored throughout the study.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis for at least 6 months before the first administration of study drug
- •Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at Screening and at Baseline
- •Have an Investigator's Global Assessment (IGA) >=3 at Screening and at Baseline
- •Have an involved body surface area (BSA) >= 10 percent (%) at Screening and at Baseline
- •Be a candidate for phototherapy or systemic treatment for psoriasis (either naïve or history of previous treatment)
排除标准
- •Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- •Has unstable cardiovascular disease, defined as a recent clinical deterioration (example [eg], unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
- •Currently has a malignancy or has a history of malignancy within 5 years before Screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration, or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study drug administration)
- •Has previously received guselkumab or ustekinumab
研究组 & 干预措施
Open-label ustekinumab
干预措施: Ustekinumab (Drug)
Double-blind guselkumab
干预措施: Guselkumab (Drug)
Double-blind guselkumab
干预措施: Placebo for ustekinumab (Drug)
Double-blind ustekinumab
干预措施: Ustekinumab (Drug)
Double-blind ustekinumab
干预措施: Placebo for guselkumab (Drug)
结局指标
主要结局
Number of Visits at Which Participants Achieved an Investigator's Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40
时间窗: Week 28 through Week 40
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
次要结局
- Number of Visits at Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 90 Response From Week 28 Through Week 40(Week 28 through Week 40)
- Number of Visits at Which Participants Achieved an IGA Score of Cleared (0) From Week 28 Through Week 40(Week 28 through Week 40)
- Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) at Week 28(Week 28)