A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2b Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects With Active Psoriatic Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 391
- 试验地点
- 1
- 主要终点
- Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to demonstrate the safety and efficacy of SUNPG1623
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subject has provided written informed consent
- •Subject is ≥ 18 years of age at time of Screening
- •Subject must be on stable dose of NSAID for ≥ 4 weeks prior to initiation of IMP
- •Subject has a negative evaluation for TB within 4 weeks before initiating IMP
- •Subject has a diagnosis of PsA (by the Classification of Psoriatic Arthritis [CASPAR] criteria) with symptoms present for at least 6 months.
- •Subject has ≥ 3 tender and ≥ 3 swollen joints at Screening and Baseline.
排除标准
- •Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pretreatment condition
- •Subject has an active infection or history of infections
- •Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease
- •Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus
研究组 & 干预措施
SUNPG1623 dose II
mid range dose
干预措施: PLACEBO (Drug)
SUNPG1623 dose I
low range dose
干预措施: SUNPG1623 I (Drug)
SUNPG1623 dose II
mid range dose
干预措施: SUNPG1623 II (Drug)
SUNPG1623 dose III
mid range dose
干预措施: SUNPG1623 III (Drug)
SUNPG1623 dose III
mid range dose
干预措施: PLACEBO (Drug)
SUNPG1623 dose IV
mid range dose to high dose
干预措施: SUNPG1623 IV (Drug)
SUNPG1623 dose IV
mid range dose to high dose
干预措施: PLACEBO (Drug)
Placebo
mid range dose to high dose
干预措施: PLACEBO (Drug)
结局指标
主要结局
Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate
时间窗: week 24
The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein. For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.
次要结局
- Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate(week 52)
- Proportion of Subjects Achieving American College of Rheumatology50 Response Rate(week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52)
- Proportion of Subjects Achieving American College of Rheumatology70 Response Rate(week 1, week 4, week 8, week 12, week 16, week 20, week 24, and week 52)
- Change From Baseline in Tender Joint Counts(Week 52)
- Change From Baseline in Swollen Joint Counts(Week 52)
- Physician Global Assessment of Disease Activity Visual Analog Scale(week 1, week 4, week 8, week 12, week 16, week 20, and week 24)
- Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale(Week 52)
- Patient's Global Assessment of Disease Activity(week 1, week 4, week 8, week 12, week 16, week 20 and week 24)
- Change From Baseline in Patient's Global Assessment of Disease Activity(Week 52)
- Patient's Pain Assessment(week 1, week 4, week 8, week 12, week 16, week 20, and week 24)
- Change From Baseline in Patient's Pain Assessment(Week 52)
- Health Assessment Questionnaire- Disability Index(week 1, week 4, week 8, week 12, week 16, week 20, and week 24)
- Change From Baseline in Health Assessment Questionnaire- Disability Index(Week 52)
- Acute Phase C - Reactive Protein(Week 52)
- Erythrocyte Sedimentation Rate(week 1, week 4, week 8, week 12, week 16, week 20, and week 24)
- Change From Baseline in Erythrocyte Sedimentation Rate(Week 52)
- The Proportion of Subjects Who Require Adjustment of Background Therapy(Week 16)
- Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate(week 1, week 4, week 8, week 12, week 16, week 20, week 24 and Week 52)
- Minimal Disease Activity(week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52)
- Change From Baseline in Leeds Dactylitis Index (LDI)(Week 52)
- Change From Baseline in Leeds Enthesitis Index (LEI)(Week 52)