A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Preliminary Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR1501 Injection by in Patients With Active Axial Spondyloarthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- ASAS 20 responder
研究概览
简要总结
Dosage: 100mg or 200mg or 300mg Administration frequency: Q2W administration in the first 4 weeks (W0, W2, W4), and subsequent Q4W administration (W8, W12) Administration: subcutaneous injection Specifications: 100mg/ 1mL/bottle or placebo 0mg/1ml/ bottle
详细描述
This is a randomized, double-blind, placebo-controlled phase II clinical trial evaluating the preliminary efficacy, safety, pharmacokinetic, and immunogenicity of GR1501 injection (IL-17A antiboby) at different doses and dosing frequency in patients with active axial spinal arthritis.
A total of 160 patients were enrolled in the planned trial, and after passing the screening period of 2 weeks, they were randomly assigned to the 100mg group, 200mg group, 300mg group or placebo group according to 1:1:1:1.After the completion of the 16-week administration period, the follow-up period (~24 weeks) was initiated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According with the diagnosis of axial spondyloarthritis (axSpA) by the Assessment of Spondyloarthritis International Society (ASAS);,
- •During the screening period, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4 points and the Spinal Pain (BASDAI Article 2) NRS score ≥ 4 points;
排除标准
- •Previous or current Crohn's disease;
- •Suffering from ulcerative enteritis and requiring immunosuppressive therapy at present;
结局指标
主要结局
ASAS 20 responder
时间窗: Week 16
clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of 20% or more and absolute improvement of at least 1 units (on a scale of 0 \[least\] to 10 \[worst\]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (worsening of at least 20% an absolute Worsening of at least 1 unit) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores
次要结局
- ASAS 40 responder(Week 2, 4, 8, 12, 16, 20, 24)
- ASAS 5/6 responder(Week 12, 16, 24)
- Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score(Week 2, 4, 8, 12, 16, 20, 24)
- Magnetic Resonance Imaging (MRI) Inflammatory Scores(Week 16, 24)
- 17. Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Week 2, 4, 8, 12, 16, 20, 24)
- Number of adverse events to measure Safety of subcutaneously administered GR1501(to Week 24)