A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants With Moderately to Severely Active Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 25
- 主要终点
- Change From Baseline on the Disease Activity Score Modified to Include the 28 Diarthrodial Joint Count-High-Sensitivity C-Reactive Protein (DAS28-hsCRP)
研究概览
简要总结
The reason for this study is to see if the study drug LY3462817 is safe and effective in participants with moderately to severely active rheumatoid arthritis (RA).
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
- Double (Participant, Investigator)
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
- •Have a diagnosis of adult onset RA as defined by the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for at least 3 months prior to screening
- •Have moderately to severely active RA defined by the presence of ≥6 swollen joints (based on 66 joint count) and ≥6 tender joints (based on 68 joint count) at screening and baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility
- •Have at least 1 of the following:
- •positive test results for rheumatoid factor or anti-citrullinated peptide antibodies at screening, OR
- •previous radiographs documenting bony erosions in hands or feet consistent with RA
- •Have C-reactive protein (CRP) >1.2 times upper limit of normal (ULN) per the central laboratory at screening
- •Demonstrated an inadequate response to, or loss of response or intolerance to:
- •at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) treatment OR
- •at least 1 biologic DMARD/tsDMARD treatment
排除标准
- •Class IV RA according to ACR revised response criteria
- •Have a diagnosis or history of malignant disease within 5 years prior to baseline, with the exceptions of:
- •basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, or
- •cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline
- •Have presence of confirmed cervical dysplasia
- •Have had various types of infection within 3 months of screening or develops any of these infections before the randomization visit.
- •Have any of the following:
- •Human immunodeficiency virus (HIV) infection
- •Current infection with hepatitis B virus (HBV) (i.e., positive for hepatitis B surface antigen and/or polymerase chain reaction (PCR) positive for HBV DNA
- •Current infection with hepatitis C virus (HCV) (i.e., positive for HCV RNA)
- •Active tuberculosis (TB)
- •Have failed more than 2 biologic DMARDs (bDMARDs) or tsDMARDs (e.g. excluded if have received 2 bDMARDs and 1 tsDMARD)
研究组 & 干预措施
LY3462817 300 mg
Participants received Intravenous (IV) infusion of 300 mg LY3462817 solution.
干预措施: LY3462817 (Drug)
LY3462817 700 mg
Participants received IV infusion of 700 mg LY3462817 solution.
干预措施: LY3462817 (Drug)
Placebo
Participants received IV infusion of 0.9% sodium chloride solution (Placebo).
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline on the Disease Activity Score Modified to Include the 28 Diarthrodial Joint Count-High-Sensitivity C-Reactive Protein (DAS28-hsCRP)
时间窗: Baseline, Week 12
Disease Activity Score (DAS) based on a 28 joint count hsCRP consisted of composite numerical score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), hsCRP (mg/mL), and participant's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP equals to (=) 0.56\*square root (sqrt) (TJC28) plus (+) 0.28\*sqrt (SJC28)+ 0.014\* participant's global assessment of disease activity + 0.36\*natural log(hsCRP+1) +0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity. Least Square Mean (LS Mean) was calculated using mixed model repeated measures (MMRM) with treatment, strata (previous RA therapy population), baseline value, visit, treatment-by-visit interaction as fixed factors.
次要结局
- Percentage of Participants Achieving 70% Improvement in American College of Rheumatology Criteria (ACR70)(Week 12)
- Pharmacokinetics (PK): Observed Concentration of LY3462817(Week 12)
- Percentage of Participants Achieving 50% Improvement in American College of Rheumatology Criteria (ACR50)(Week 12)
- Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)(Baseline, Week 12)
- Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20)(Week 12)
- Change From Baseline for Mean Simplified Disease Activity Index (SDAI)(Baseline, Week 12)
- Change From Baseline for Mean Clinical Disease Activity Index (CDAI)(Baseline, Week 12)