A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703 in Patients With Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Oscotec Inc.
- 入组人数
- 163
- 试验地点
- 40
- 主要终点
- Change in Disease Activity Score
研究概览
简要总结
This study will evaluate the safety and efficacy of SKI-O-703 compared with placebo, in patients with active rheumatoid arthritis (RA) who have had an inadequate response to conventional synthetic disease-modifying agents. Patients will be randomly assigned to one of 4 groups and will receive one of three doses of SKI-O-703 or placebo, administered orally twice daily for 12 weeks.
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
- •Patients must provide written, signed, informed consent.
- •Patients must have a diagnosis of Rheumatoid Arthritis (RA) according to American College of Rheumatology (ACR) criteria or the 2010 ACR/European League Against Rheumatism classification, for at least 6 months prior to first administration of study drug.
- •Patients must have active RA at screening and baseline (Day 1 of the study).
- •Patients who have active disease despite csDMARD (conventional synthetic disease-modifying antirheumatic drugs) therapy for at least 3 months prior to Day 1 of the study.
- •Patients must have had an inadequate response to previous anti-TNF⍺ (anti-tumor necrosis factor alpha) biological agent(s) for the treatment of RA and meet the washout period prior to Day 1 of the study.
排除标准
- •Patients receiving oral agents, except for medications listed in inclusion criteria for the treatment of RA.
- •Patients who have previously received any other or biological agent for the treatment of RA, other than anti-TNF⍺ inhibitor(s).
- •Patients who have a current or past history of hepatitis B virus (HBV) infection; positive test for hepatitis C virus (HCV) antibody; positive test for human immunodeficiency virus (HIV); history of or concurrent interstitial pneumonia; acute infection requiring oral antibiotics within 2 weeks, or parenteral injection of antibiotics within 4 weeks prior to first administration of the study drug; other serious infection within 6 months prior to first administration of study drug; recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to first administration of the study drug; past or current granulomatous infections or other severe or chronic infection; positive test for tuberculosis (TB) or other evidence of TB.
- •Patients with uncontrolled diabetes mellitus, or uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg).
- •Patients with any other inflammatory or rheumatic diseases that could impact the evaluation of the effect of the study drug.
- •Patients with a history of malignancy within 5 years prior to first administration of the study drug, except completely excised and cured squamous cell carcinoma, carcinoma of the cervix in situ, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.
- •New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled cardiac disease or heart attack within 6 months prior to first administration of the study drug.
- •Female patients who are currently pregnant, breastfeeding or planning to become pregnant or breastfeed within 6 months of the last dose of the study drug.
- •Other protocol-defined inclusion/exclusion criteria could apply.
研究组 & 干预措施
SKI-O-703 100 mg
干预措施: SKI-O-703 (Drug)
SKI-O-703 200 mg
干预措施: SKI-O-703 (Drug)
SKI-O-703 400 mg
干预措施: SKI-O-703 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Disease Activity Score
时间窗: Baseline and Week 12
Mean change from baseline in disease activity score for 28 joints (DAS28) using hsCRP (high sensitivity C-reactive protein). Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), and high sensitivity C-reactive protein (hsCRP) (milligrams per liter). DAS28 was calculated using following formula: DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(hsCRP+1)\*1.10+1.15. High DAS28-hsCRP value indicates more severe disease activity, by value of \>5.1 indicating relatively high disease activity, whereas value of \<3.2 indicating achieved lower disease activity (no theoretical full range available).
次要结局
- Adverse Events (AEs)(Up to Week 16)
- • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score(Baseline and Weeks 2, 4 8 and 12)
- Serious Adverse Events (SAEs)(Up to Week 16)
- • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score(Baseline and Weeks 2, 4 8 and 12)
- • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score(Baseline and Weeks 2, 4 8 and 12)
- Health Assessment Questionnaire-Disability Index (HAQ-DI) Score(Baseline and Weeks 2, 4 8 and 12)