A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 182
- 试验地点
- 103
- 主要终点
- Proportion of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 12
研究概览
简要总结
Researchers are looking for new ways to treat rheumatoid arthritis (RA). Methotrexate (MTX) is a standard (usual) treatment for RA. However, MTX and other current treatments may not work well to treat RA symptoms for many people.
This study will help find out if a study medicine called tulisokibart can treat symptoms of active RA in people who are taking MTX. 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 RA 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 12-week Placebo-controlled Period and a 116-week Long-term Extension (LTE), which is composed of a 44-week Main Extension and an 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 rheumatoid arthritis (RA) and fulfillment of 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria
- •Has active disease defined as ≥6 tender joints (based on 68 joints) and ≥6 swollen joints (based on 66 joints)
- •Has current treatment with oral or parenteral methotrexate (MTX) therapy
- •Has history of one of the following: a) biologic disease-modifying antirheumatic drug (bDMARD) naïve, or b) bDMARD-Inadequate Response (IR)/intolerant up to a maximum of 2 classes of bDMARDS
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 RA (such as, but not limited to, psoriatic arthritis, systemic lupus erythematosus, gout, systemic sclerosis, myositis, pseudogout, etc) or any other condition that may, in the judgment of the investigator, interfere with the assessment of RA
- •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 or its excipients
研究组 & 干预措施
High-dose tulisokibart
Participants receive background therapy of methotrexate (MTX) PLUS a high dose of tulisokibart
干预措施: Methotrexate (Drug)
High-dose tulisokibart
Participants receive background therapy of methotrexate (MTX) PLUS a high dose of tulisokibart
干预措施: Tulisokibart (Drug)
Medium-dose tulisokibart
Participants receive background therapy of MTX PLUS a medium dose of tulisokibart.
干预措施: Tulisokibart (Drug)
Medium-dose tulisokibart
Participants receive background therapy of MTX PLUS a medium dose of tulisokibart.
干预措施: Methotrexate (Drug)
Low-dose tulisokibart
Participants receive background therapy of MTX PLUS a low dose of tulisokibart and are rerandomized at week 12 to a medium or high dose of tulisokibart.
干预措施: Tulisokibart (Drug)
Low-dose tulisokibart
Participants receive background therapy of MTX PLUS a low dose of tulisokibart and are rerandomized at week 12 to a medium or high dose of tulisokibart.
干预措施: Methotrexate (Drug)
Placebo
Participants receive background therapy of MTX PLUS a dose-matched tulisokibart placebo and are re-randomized at week 12 to a medium or high dose of tulisokibart.
干预措施: Methotrexate (Drug)
Placebo
Participants receive background therapy of MTX PLUS a dose-matched tulisokibart placebo and are re-randomized at week 12 to a medium or high dose of tulisokibart.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 12
时间窗: Week 12
The ACR20 response is a composite measure to evaluate disease activity in RA. ACR20 response is defined as a ≥20% improvement in: a) swollen joint count (66 joints) and tender joint count (68 joints) (0= Absent; 1= Present) and b) ≥20% improvement in ≥3 of the following 5 assessments and questionnaires: 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) serum values, a lower value indicates less inflammation. The proportion of participants with ACR20 response at Week 12 will be presented.
次要结局
- Number of Participants Who Experience One or More Adverse Events (AEs)(Up to approximately Week 142)
- Proportion of Participants Achieving American College of Rheumatology 50% Response Criteria (ACR50) at Week 12(Week 12)
- Proportion of Participants Achieving American College of Rheumatology 70% Response Criteria (ACR70) at Week 12(Week 12)
- Proportion of Participants Achieving Low Disease Activity (LDA) based on Disease Activity Score 28 Using C-Reactive Protein (DAS28-CRP)(Week 12)
- Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 12(Baseline and Week 12)
- Number of Participants Who Discontinue Study Intervention Due to an AE(Up to approximately Week 128)