A Double-Blind, Placebo-Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28-Day Course of INCB047986 in Subjects With Active Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 主要终点
- Percentage of Participants Achieving American College of Rheumatology, 20% Improvement (ACR20)
研究概览
简要总结
The purpose of this study is to explore the safety, tolerability and efficacy of INCB047986, in subjects with moderate to severe rheumatoid arthritis.
详细描述
This will be a double-blind, placebo-controlled study with 4 parallel treatment groups. Subjects will be screened for up to 28 days before study drug administration to ensure that all eligibility criteria are met. On Day 1, subjects will be randomized to 1 of 4 dose groups of 15 subjects each (INCB047986 4 mg, 8 mg, 12 mg, or placebo QD). Study drug will be self administered on Days 1 through 28. A follow-up telephone call to the subject to assess safety will occur at Day 42. A final safety and efficacy evaluation will be performed at the Day 58 visit.
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
- •Men or women aged 18 to 75 years, inclusive.
- •Body mass index between 18 and 40 kg/m^2, inclusive.
- •Subjects must have a diagnosis of rheumatoid arthritis (RA) of at least 6 months' duration at the time of screening and must satisfy the ACR/European League Against Rheumatism (EULAR) 2010 Classification Criteria (Appendix B).
- •Subjects must have active moderate to severe RA as determined by the following:
- •≥ 6 tender joints (28 joint count),
- •≥ 4 swollen joints (28 joint count), and
- •CRP level ≥ 6 mg/L.
- •Subjects must have a negative tuberculosis (TB) test (QuantiFERON®-TB Gold test or purified protein derivative (PPD)) at screening.
排除标准
- •Current or recent history of severe and/or progressive uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease.
- •Current or recent history (< 30 days before screening and/or < 45 days before randomization) of a clinically meaningful bacterial, fungal, parasitic, or mycobacterial infection.
- •Onset of RA before the age of 16 years.
- •History of known or currently suspected inflammatory disease other than RA
- •Current regimen of prednisone or equivalent with an average daily dose of > 10 mg or having been treated with a stable daily dose ≤ 10 mg for < 6 weeks.
- •Previous treatment with at Janus kinase (JAK) inhibitor.
- •Significant impairment of bone marrow function present at screening
- •Receipt of any live vaccine within 2 months before screening or anticipated need for a live vaccine within the 2 months after last dose of study drug.
研究组 & 干预措施
INCB047986 4 mg QD
INCB047986 4 mg will be orally self-administered once daily (QD) for 28 days.
干预措施: INCB047986 (Drug)
INCB047986 8 mg QD
INCB047986 8 mg will be orally self-administered once daily (QD) for 28 days.
干预措施: INCB047986 (Drug)
INCB047986 12 mg QD
INCB047986 12 mg will be orally self-administered once daily (QD) for 28 days.
干预措施: INCB047986 (Drug)
INCB047986 placebo QD
INCB047986 placebo will be orally self-administered once daily (QD) for 28 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving American College of Rheumatology, 20% Improvement (ACR20)
时间窗: Baseline through Day 28
Percentage of participants with adverse events, changes in electrocardiograms (ECGs), vital signs, physical examinations, or clinical laboratory evaluations
时间窗: Baseline through day 28
次要结局
- Percentage of subjects achieving a DAS28 of ≤ 2.6 at the Day 28 visit.(Day 28)
- Change in individual American College of Rheumatology (ACR) assessments.(Day 28)
- Preliminary pharmacokinetic (PK)(Evaluated after 15 days of treatment)
- Percentage of subjects achieving ACR20 at each visit assessed.(Baseline, Day 8, 15 and Follow-Up)
- Percentage of subjects achieving American College of Rheumatology, 50% improvement (ACR50) at each visit assessed.(Baseline, Day 8, 15 28 and Follow-Up)
- Percentage of subjects achieving American College of Rheumatology, 70% improvement (ACR70) at each visit assessed.(Baseline, Day 8, 15 28 and Follow-Up)
- Change in Disease Activity Score - 28-joint count (DAS28) C-reactive protein (CRP) at the Day 28 visit.(Day 28)
- Change in DAS28 erythrocyte sedimentation rate (ESR) at the Day 28 visit.(Day 28)
- Percentage of subjects achieving a DAS28 of ≤ 3.2 at the Day 28 visit.(Day 28)