A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Radiographic Axial Spondyloarthritis (Ankylosing Spondylitis)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 315
- 试验地点
- 163
- 主要终点
- Percentage of Participants Achieving Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 16
研究概览
简要总结
Researchers are looking for new ways to treat radiographic axial spondyloarthritis (r-axSpA). R-axSpA is a type of arthritis that causes pain, stiffness, and inflammation (swelling) in the spine and joints in the pelvis (hip bone). Radiographic means the damage it causes can be seen on X-rays.
This study will help find out if a study medicine called tulisokibart can treat symptoms of r-axSpA. Researchers will look at different doses of tulisokibart.
Researchers want to know if at least one of the study doses of tulisokibart works better than a placebo to improve r-axSpA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.
详细描述
This study consists of a 16-week Placebo-controlled Period and a 124-week Long-term Extension (LTE), which is composed of a 40-week Main Extension and an 84-week Optional 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Has a clinical diagnosis of axial spondyloarthritis (axSpA) and meets the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA including ≥3 months of back pain with age at symptom onset <45 years
- •Meets the radiographic criterion of the modified New York criteria for ankylosing spondylitis (AS) as determined by central reading at Screening
- •Has active disease at Screening and Randomization
- •Has a history of inadequate response (IR)/intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs) and is biologic disease-modifying antirheumatic drug (bDMARD)-naive, or has a history of IR/intolerance to up to a maximum of 2 bDMARD classes
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than radiographic axial spondyloarthritis (r-axSpA) (such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis (PsA), systemic sclerosis, myositis, etc.), or any other conditions that may, in the judgment of the investigator, interfere with the assessment of r-axSpA
- •Has a history of cancer (except fully treated non-melanoma skin cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years
- •Has any active infection
- •Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
研究组 & 干预措施
Medium-dose tulisokibart
Participants receive a medium dose of tulisokibart.
干预措施: Tulisokibart (Drug)
Low-dose tulisokibart
Participants receive a low dose of tulisokibart and are rerandomized at week 16 to a medium or high dose of tulisokibart.
干预措施: Tulisokibart (Drug)
Placebo
Participants receive a matched placebo dose and are rerandomized at week 16 to a medium or high dose of tulisokibart.
干预措施: Placebo (Drug)
High-dose tulisokibart
Participants receive a high dose of tulisokibart.
干预措施: Tulisokibart (Drug)
结局指标
主要结局
Percentage of Participants Achieving Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 16
时间窗: Week 16
ASAS 40 is defined as a relative improvement of ≥40% and an absolute improvement of ≥2 units from baseline in ≥3 of 4 domains, with no deterioration in the fourth domain. The 4 domains include Patient Global Assessment (PtGA), total spinal pain, physical function, and morning stiffness. Each domain is measured on a 10-point numeric scale from 0 = no disease symptoms/impact to 10 = extreme disease symptoms/impact, with a higher score indicating more severe impairment.
次要结局
- Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1 at Week 16(Week 16)
- Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16(Baseline and Week 16)
- Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for Spine at Week 16(Baseline and Week 16)
- Change From Baseline in the SPARCC MRI Score for Sacroiliac Joint (SIJ) at Week 16(Baseline and Week 16)
- Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) at Week 16(Baseline and Week 16)
- Change From Baseline in BASDAI at Week 16(Baseline and Week 16)
- Change From Baseline in Total Spinal Pain Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 at Week 16(Baseline and Week 16)
- Change From Baseline in Nocturnal Spinal Pain at Week 16(Baseline and Week 16)
- Change From Baseline in Assessment of Spondyloarthritis International Society Health Index (ASAS HI) at Week 16(Baseline and Week 16)
- Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 16 in the Subgroup of Participants With Enthesitis (MASES>0) at Baseline(Baseline and Week 16)
- Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) at Week 16(Baseline and Week 16)
- Change From Baseline in Bath Ankylosing Spondylitis Metrology Index Linear (BASMI lin) at Week 16(Baseline and Week 16)
- Number of Participants With One or More Adverse Events (AEs)(Up to approximately 154 weeks)
- Number of Participants Who Discontinue Study Intervention Due to an AE(Up to approximately 140 weeks)