A Multicenter, Randomized, Double-blind, Double Dummy,placebo and Positive Controlled,phase II Clinical Study to Evaluate the Efficacy and Safety of 608 in Patients with Ankylosing Spondylitis (AS)
试验速览
- 阶段
- 2 期
- 状态
- 进行中(未招募)
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 20 Response.
研究概览
简要总结
This study will evaluate the effect and safety of 608 in patients with AS.
详细描述
The purpose of this study is to demonstrate the clinical efficacy, safety and tolerability of 608 compared to placebo and positive drug in patients with AS.
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)
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
- •Female and male patients at least 18 years of age at the time of screening.
- •Participant with a clinical diagnosis of ankylosing spondylitis (AS) and meeting the modified New York criteria for AS.
- •Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4 and a Patient's Assessment of Total Back Pain score >= 4 based on a 0 - 10 numeric rating scale (NRS) at the Screening and Baseline visits.
- •If entering the study on concomitant NSAIDs for AS, participant must be on stable dose(s) for at least 2 weeks prior to the Baseline visit.
排除标准
- •Patients with other uncontrolled active inflammatory diseases.
- •Clinical laboratory tests and other tests that reveal abnormalities with clinical significance
- •Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
- •History of cancer.
- •Known or suspected history of immunosuppression.
研究组 & 干预措施
608 Dose A
608 Dose A subcutaneous (SC) injection.
干预措施: 608 Dose A (Drug)
608 Dose B
608 Dose B subcutaneous (SC) injection.
干预措施: 608 Dose B (Drug)
608 Dose C
608 Dose C subcutaneous (SC) injection.
干预措施: 608 Dose C (Drug)
Positive control group
Adalimumab subcutaneous (SC) injection.
干预措施: Adalimumab (Drug)
Placebo
Placebo subcutaneous (SC) injection.
干预措施: Placebo (Drug)
结局指标
主要结局
The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 20 Response.
时间窗: Week 16.
Assessment of Spondylo Arthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a NRS; 2. Patient's assessment of back pain, measured on a NRS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by NRS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by NRS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). ASAS 20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain. A higher score on the NRS signifies higher severity.
次要结局
- The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response.(Week 16.)
