A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Psoriatic Arthritis.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 52
- 主要终点
- Percentage of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 16
研究概览
简要总结
Researchers are looking for new ways to treat Psoriatic Arthritis (PsA). This study will help find out if a study medicine called tulisokibart (MK-7240) can treat symptoms of active PsA. This study assesses the efficacy, safety, and tolerability of tulisokibart in adult participants with active PsA.
In this study, researchers will look at different doses of tulisokibart. Researchers want to learn if at least one of the study doses of tulisokibart works better than a placebo to lessen PsA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.
详细描述
This study consists of a 16-week Placebo-controlled Period and a 112-week Long-term Extension (LTE), which is composed of a 40-week Main Extension and a 72-week Optional Extension.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Has a clinical diagnosis of PsA and fulfillment of the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at Screening, with symptom onset ≥6 months before Screening.
- •Has a diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
- •Has history of biologic disease-modifying antirheumatic drug (bDMARD)-naïve or bDMARD-inadequate response/intolerant.
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than PsA (such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, myositis, etc), or any other conditions that may, in the judgment of the investigator, interfere with the assessment of PsA.
- •Has a skin condition diagnosis, other than psoriasis that may, in the judgment of the investigator, interfere with the assessment of psoriasis.
- •Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years before Randomization.
- •Has any active infection.
- •Has known allergies, hypersensitivity, or intolerance to tulisokibart of its excipients.
研究组 & 干预措施
Placebo Regimen
Participants receive a matched placebo dose and are rerandomized at Week 16 to a medium or high dose of tulisokibart.
干预措施: Placebo (Drug)
Low-Dose Regimen
Participants receive a low dose of tulisokibart and are rerandomized at Week 16 to a medium or high dose of tulisokibart.
干预措施: Tulisokibart (Drug)
High-Dose Regimen
Participants receive a high dose of tulisokibart.
干预措施: Tulisokibart (Drug)
Medium-Dose Regimen
Participants receive a medium dose of tulisokibart.
干预措施: Tulisokibart (Drug)
结局指标
主要结局
Percentage of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 16
时间窗: Week 16
ACR20 response is defined as a ≥20% improvement in a) tender joint count based on 68 joints and swollen joint count based on 66 joints (0= absent; 1= present) and b) ≥20% improvement in ≥3 of 5 components: i) Health Assessment Questionnaire Disability Index (HAQ-DI) (0=without any difficulty; 3= unable to do; a higher score=worse disability); ii) Physician Global Assessment of Disease Activity (PGA) (0= not active to 10= very active; a higher score= more active disease); iii) Patient's Global Assessment of Disease Activity (PtGA) (0= not active to 10= very active; a higher score= more active disease); iv) Patient assessment of Pain Severity (0= no pain to 10= most severe pain; a higher score = more pain); v) High-sensitivity C-reactive protein (hsCRP) blood values (lower value indicates less inflammation).
American College of Rheumatology Response Criteria (ACR) 20% (ACR20)
时间窗: Week 16
ACR20 is defined as a 20% or greater improvement in a) tender joint count based on 68 joints and swollen joint count based on 66 joints and b) 20% or greater improvement in \>3 of the 5 components of i) Health Assessment Questionnaire Disability Index (HAQ-DI), ii) Physician Global Assessment of Disease Activity (PGA), iii) Patient Global Assessment (PtGA), iv) Patient Assessment of Pain Severity, and v) high sensitivity C-reactive protein (hsCRP).
次要结局
- Percentage of Participants Achieving American College of Rheumatology 50% Response Criteria (ACR50) at Week 16(Week 16)
- Percentage of Participants Achieving American College of Rheumatology 70% Response Criteria (ACR70) at Week 16(Week 16)
- Number of Participants with ≥1 Adverse Event(Up to approximately Week 142)
- Number of Participants Who Discontinue Study Intervention Due to an AE(Up to approximately Week 128)
- ACR 50% (ACR50)(Week 16)
- ACR70(Week 16)
- Change from Baseline in HAQ-DI Score at Week 16(Baseline and Week 16)
- Number of Participants with ≥1 Adverse events(Up to ~Week 147)