Phase II, Double-Blind, Placebo-Controlled, Randomized Study Evaluating the Efficacy and Safety of Vilamakitug in Participants With Active Axial Spondyloarthritis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Percentage of participants achieving ASAS40.
研究概览
简要总结
The goal of this clinical trial is to find out if the study drug will work as a new therapy for axSpA patients. This study is placebo-controlled, and evaluates if study drug can treat symptoms of axSpA, including global disease activity, pain, function and inflammation.
详细描述
Researchers will compare vilamakitug to a placebo (no active drug) to see if the study drug works in axSpA patients to treat symptoms. Participants will take the assigned study treatment for 16 weeks for double blind period and potentially 12 weeks for open label extension.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged ≥18 and ≤65 years, with body weight >40 kg at screening, who are willing to provide informed consent, attend all clinic visits, comply with study-related procedures and able to understand and complete study-related questionnaires.
- •Must meet the ASAS-SPARTAN 2025 revised classification criteria for axial spondyloarthritis.
- •Active disease at screening, defined by BASDAI ≥ 4 and ASDAS-CRP ≥ 2.1
- •Participants should have received prior NSAIDs or have documented inadequate response to NSAIDs
- •Participants may be biological DMARD-naïve or have documented failure of no more than 1 prior biologic DMARD (≥12 weeks)
排除标准
- •History of treatment with vilamakitug
- •Any prior exposure to > 1 biologic DMARD
- •Any exposure to JAK or TYK2 inhibitors
- •Current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within a year prior to enrollment
- •Participation in another interventional clinical study within 30 days or 5 half-lives (whichever is longer) prior to enrollment, and during the study
- •Female participants who are pregnant or breastfeeding at screening, or who intend to become pregnant during the study or within 8 weeks after the last dose of investigational product (IP), and male participants who intend to father a child during the study or within 8 weeks after the last dose of IP.
研究组 & 干预措施
placebo
placebo
干预措施: placebo (Drug)
vilamakitug
weekly dose of vilamakitug
干预措施: vilamakitug (Drug)
结局指标
主要结局
Percentage of participants achieving ASAS40.
时间窗: Baseline to week 16
ASAS40 response is defined at least a 40% improvement in at least three of the four main ASAS domains, with no worsening in the remaining domain: Patient Global Assessment of Disease Activity (Q3 of ASDAS-CRP), Pain Assessment (BASDAI Q2), physical function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]), and Inflammation (represented by the mean of the two morning stiffness BASDAI questions Q5 and Q6).
次要结局
- Patient Global Assessment of Disease Activity (PGADA) using Q3 of ASDAS-CRP(Baseline to week 16)
- Inflammation, defined as the mean of Questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Baseline to week 16)
- Spinal pain [Numeric Rating Scale (NRS) using Question 2 of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)](Baseline to week 16)
- Physical function using Bath Ankylosing Spondylitis Functional Index (BASFI)(Baseline to week 16)