A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Phase 2 Study of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 32
- 主要终点
- Percentage of Participants Who Achieve Remission of Arthritis and/or Rash Defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as baricitinib in participants with systemic lupus erythematosus.
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 received a diagnosis of SLE at least 24 weeks prior to screening, meeting the American College of Rheumatology (ACR) 1982 revised criteria OR the 2012 Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria.
- •Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA) as assessed by a central laboratory at screening.
- •Have a SLEDAI-2K score ≥4 based on clinical symptoms (not including lab values) at randomization.
- •Have active arthritis and/or active rash as defined by the SLEDAI-2K at randomization.
排除标准
- •Have active severe lupus nephritis.
- •Have active severe central nervous system (CNS) lupus.
- •Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
- •Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
- •Are currently receiving oral corticosteroids at doses >20-milligrams per day of prednisone (or equivalent) or have adjusted the dose of corticosteroids within 2 weeks of planned randomization.
- •Have started treatment with or adjusted the dose of nonsteroidal anti-inflammatory drugs (NSAIDs) (for which the NSAID use is intended for treatment of signs and symptoms of SLE) within 4 weeks of planned randomization.
- •Have started treatment with or adjusted the dose of an antimalarial within 12 weeks of planned randomization.
- •Have started treatment with or adjusted the dose of an immunosuppressant within 12 weeks of planned randomization.
- •Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.
研究组 & 干预措施
2 mg Baricitinib
Participants received 2 (milligrams) mg of Baricitinib tablet orally once a day for 24 weeks.
干预措施: Baricitinib (Drug)
4 mg Baricitinib
Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.
干预措施: Baricitinib (Drug)
Placebo
Participants received Placebo orally once daily (QD) for 24 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Achieve Remission of Arthritis and/or Rash Defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
时间窗: Week 24
Participants were defined as responder as follows using SLEDAI-2K definitions of arthritis and rash. If only arthritis is present at baseline, then arthritis must be absent at Week 24 to meet the primary endpoint. If only rash is present at baseline, then rash must be absent at Week 24 to meet the primary endpoint. If both arthritis and rash are present at baseline, then the primary endpoint is met if either arthritis, or rash, or both arthritis and rash are absent at Week 24.
次要结局
- Change From Baseline in SLEDAI-2K Score(Baseline, Week 24)
- Percentage of Participants Who Achieve SLE Responder Index 4 (SRI-4) Response(Week 24)
- Population Pharmacokinetics (PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss)(Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: Predose)
- Change From Baseline in Patient's Global Assessment of Disease Activity(Baseline, Week 24)
- Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss)(Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: Predose)