A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VTX958 in Patients With Active Psoriatic Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 205
- 试验地点
- 46
- 主要终点
- Proportion of participants achieving 20% improvement in American College of Rheumatology criteria (ACR20) at Week 16
研究概览
简要总结
The objective of this study is to evaluate if VTX958 is safe and effective in adult participants with active Psoriatic Arthritis. Approximately 195 eligible participants will take VTX958 Dose A, VTX958 Dose B, or matching placebo (no active drug) for 16 weeks and then move on to a 36 week Long Term Extension (LTE). The study will include 16 weeks of treatment, 36 weeks of LTE, and a 30-day follow-up period.
详细描述
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two doses of VTX958 tablets, Dose A and Dose B, in adults with active Psoriatic Arthritis. Approximately 195 participants will be assigned in a 1:1:1 ratio to one of three groups, VTX958 Dose A, VTX958 Dose B, or placebo, for 16 weeks and then move on to a 36 week Long Term Extension (LTE). The study consists of a 30-day screening period, a 16 week double-blind treatment period, 36 weeks of LTE, and a 30 day follow-up period.
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)
盲法说明
The study has a double-blind design, meaning that the participant, care provider, and investigator will not know what treatment group each participant has been assigned to. This blinding will last from randomization until the end of the study.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Psoriatic Arthritis for 6 months or more prior to Screening
- •Documented history or active signs of at least 1 confirmed lesion of plaque psoriasis and/or nail changes attributed to psoriasis
- •Active PsA as defined by 3 or more swollen joints and 3 or more tender joints at Screening and Day 1
- •Women must not be of childbearing potential or must agree to use a highly effective contraception during the study and for 30 days after the last dose of the study product
- •Men with a partner who is of childbearing potential must agree to use condoms during the study and for 90 days after the last dose of study product
排除标准
- •Has non-plaque psoriasis at Screening or Day 1
- •Has inflammatory bowel disease or active uveitis
- •Has a history of chronic or recurrent infectious disease
- •Has a known immune deficiency or is immunocompromised
- •Has hepatitis B or hepatitis C infection, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or active tuberculosis (TB) at screening
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
VTX958 Dose A
干预措施: Dose A VTX958 (Drug)
VTX958 Dose B
干预措施: Dose B VTX958 (Drug)
结局指标
主要结局
Proportion of participants achieving 20% improvement in American College of Rheumatology criteria (ACR20) at Week 16
时间窗: Week 16
Number of participants reaching ACR20 at week 16, compared to the total number of participants in each cohort
Incidence of Treatment Emergent Adverse Events (TEAEs) from week 0 through week 16
时间窗: Week 16
The number and proportion of participants who have at least 1 TEAE after exposure to the study drug
次要结局
- Proportion of participants achieving 70% improvement in American College of Rheumatology criteria (ACR70) at Week 16(Week 16)
- Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) scores at Week 16(Week 16)
- Proportion of participants achieving 75% reduction in the Psoriasis Area and Severity Index (PASI75) score at Week 16, in participants with at least 3% body surface area (BSA) involvement at baseline(Week 16)
- Change from baseline in Short Form Health Survey - 36 items (SF-36) physical component score (PCS) at Week 16(Week 16)
- Proportion of participants achieving 50% improvement in American College of Rheumatology criteria (ACR50) at Week 16(Week 16)