A Randomized, Double-blind, Placebo-controlled, Phase III Study of Efficacy and Safety of GR1501 in Patients With Radiographic Axial Spondyloarthritis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 465
- 试验地点
- 1
- 主要终点
- The Proportion of Participants Who Achieve an ASAS 20 Response
研究概览
简要总结
The purpose of this trial is to demonstrate the clinical efficacy of GR1501 at week 16; and to demonstrate safety and tolerability of GR1501 compared to placebo in patients with Radiographic Axial Spondyloarthritis at week 16 and long term safety up to Week 48。 The main question it aims to answer is whether GR1501 injection was superior to placebo in the proportion of subjects with ASAS20 response at week 16 in patients with Radiographic Axial Spondyloarthritis.
详细描述
This is a randomized, double-blind, placebo-controlled, multicenter clinical study to evaluate the efficacy and safety of GR1501 injection in Radiographic Axial Spondyloarthritis, as well as a confirmatory clinical trial of immunogenicity.
This clinical trial was divided into four stages, namely screening period (W-4~W0), core treatment period (W0~W16), maintenance treatment period (W16~W32), and follow-up period (W32~W48).
target population： radiographic axial spondyloarthritis who had a inadequate response to NSAIDs or have a history of intolerance to NSAIDs.
primary outcome measure:percentage of participants achieving an ASAS20 response in week 16.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of radiographic axial spondyloarthritis (r-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria.
- •inadequate response, contraindications or intolerance to NSAIDs
排除标准
- •Total ankylosis of the spine
- •Ongoing or serious infection
- •Either a current diagnosis or a recent history of malignant disease
- •Are pregnant or breastfeeding
研究组 & 干预措施
Treatment group 1
GR1501 low dose
干预措施: GR1501 low dose (Biological)
Treatment group 2
GR1501 high dose
干预措施: GR1501 high dose (Biological)
treatment group 3
placebo
干预措施: placebo (Biological)
结局指标
主要结局
The Proportion of Participants Who Achieve an ASAS 20 Response
时间窗: week 16
ASAS20 response is defined as an improvement of ≥20% and ≥1 units in at least three of the four ASAS main domains
次要结局
- Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)(week 16，32，48)
- Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)(week 16，32，48)
- Change From Baseline in Mobility on the BASMI(week 16，32，48)
- Change From Baseline in BASDAI Response(week 16，32，48)
- The Proportion of Participants Who Achieve an ASAS 20 Response(week 2 to 48)
- The Proportion of Participants Who Achieve an ASAS 40 Response(week 2 to 48)
- The Proportion of Participants Who Achieve an ASAS 5/6 Response(week 16，32，48)
- Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)(week 16，32，48)