NCT04204603已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of CKD-506 Administered to Adult Subjects With Moderate-to- Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 38
- 主要终点
- Change from baseline in DAS28(CRP) at week 12
研究概览
简要总结
The primary objective of this study is to evaluate the effects of CKD-506 on signs and symptoms of RA in subjects with moderate-to-severe RA who are inadequate responders to methotrexate.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RA for at least 6 months prior to Screening, currently meet the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for RA, and are ACR functional class I-III.
- •Have active RA
- •Ongoing treatment with a stable dose of MTX as described below:
- •Use of oral or injectable MTX on a continuous basis for at least 12 weeks prior to Baseline and on a stable dose and route of administration between 15 mg and 25 mg/weekly for at least 8 weeks prior to Baseline and planned during the study.
- •Subjects should be on an adequate and stable dose of folic acid for at least 4 weeks prior to first administration of study treatment and planned during the study.
- •Women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least 12 weeks after the last dose of study treatment.
- •Women of childbearing potential must have a negative serum pregnancy test at Screening and urine pregnancy test at Baseline
- •Sexually active men, if not surgically sterile, must agree to use a medically acceptable form of contraception during the study and continue its use for at least 12 weeks after the last dose of study treatment.
排除标准
- •Treatments for RA as follows: JAK inhibitors at any time; use of any currently licensed biologics with DMARD properties at any time.
- •Use of oral steroids at a dose >10 mg/day of prednisone or prednisone equivalent or at a dose that has not been stable for at least 4 weeks prior to Screening.
- •Use of nonsteroidal anti-inflammatory drugs (NSAIDs) which have not been at a stable dose or route of administration for at least 2 weeks prior to Baseline and planned during the study.
- •History of tuberculosis (TB) infection.
- •Positive serology for human immunodeficiency virus 1 or 2, hepatitis B virus or hepatitis C virus.
- •Currently active infection or history of infection within the last 2 weeks of Screening or Baseline
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
CKD-506 Dose A
Experimental
干预措施: CKD-506 (Drug)
CKD-506 Dose B
Experimental
干预措施: CKD-506 (Drug)
CKD-506 Dose C
Experimental
干预措施: CKD-506 (Drug)
结局指标
主要结局
Change from baseline in DAS28(CRP) at week 12
时间窗: Baseline and week 12
次要结局
- Response to treatment based on the ACR50 criteria at Weeks 2, 4, 8, and 12(At weeks 2, 4, 8 and 12)
- Change from Baseline in DAS28(CRP) at Weeks 2, 4, and 8(Baseline and up to week 8)
- Response to treatment based on the American College of Rheumatology 20% response criteria (ACR20) at Weeks 2, 4, 8, and 12(At weeks 2, 4, 8 and 12)
- Response to treatment based on the ACR70 criteria at Weeks 2, 4, 8, and 12(At weeks 2, 4, 8 and 12)
- Change from Baseline in the duration of morning stiffness (in minutes and in severity as measured with a visual analog scale [VAS]) at Weeks 2, 4, 8, and 12(Baseline and up to week 12)
- Change from Baseline in the Short Form-36 item Health Survey (SF-36) at Weeks 4 and 12(Baseline and weeks 4, 12)
- Change from Baseline in ACRn at Weeks 2, 4, 8, and 12(Baseline and up to week 12)
- Change from Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Weeks 4 and 12(Baseline and weeks 4, 12)
- Change from Baseline in the Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, and 12(Baseline and up to week 12)
- Change from Baseline in the Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, and 12(Baseline and up to week 12)
- Response to treatment based on the achievement of Low Disease Activity (LDA) status based on each of the following definitions at Weeks 2, 4, 8,and 12: DAS28(CRP) ≤ 3.2, SDAI ≤ 11.0, CDAI ≤ 10.0 at Weeks 2, 4, 8, and 12(At weeks 2, 4, 8 and 12)
- Response to treatment based on the achievement of remission based on each of the following definitions at Weeks 2, 4, 8, and 12: DAS28(CRP) < 2.6, Boolean parameters, SDAI ≤ 3.3, CDAI ≤ 2.8 at Weeks 2, 4, 8, and 12(At weeks 2, 4, 8 and 12)
- Improvement of physical ability defined as change from Baseline in HAQ-DI ≥ 0.22 at Weeks 2, 4, 8, and 12(Baseline and up to week 12)
研究者
研究点 (38)
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