A Phase 2a Study to Evaluate the Safety and Efficacy of Namilumab in Subjects With Moderate-to-severely Active Axial Spondyloarthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 9
- 主要终点
- The Proportion of Subjects Who Achieved ASAS20 Clinical Response
研究概览
简要总结
The study will assess the effect of namilumab, a GM-CSF inhibitor, on the clinical response in subjects with axial spondyloarthritis. Subjects will receive treatment with either namilumab or placebo.
详细描述
A phase 2a proof-of-concept, randomised, double-blind, placebo-controlled study to evaluate the safety/tolerability and efficacy of 4 subcutaneous injections of namilumab (150 mg) given over 10 weeks in subjects with moderate-to-severely active axial spondyloarthritis including those previously exposed to anti- TNF therapy (NAMASTE study).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 75 years of age.
- •Diagnosis of axSpA by an appropriately qualified physician and classified using ASAS criteria ≥ 3 months prior to Baseline.
- •Bath Ankylosing Spondylitis Disease Activity Index score ≥ 4 and spinal pain score ≥ 40, at screening and Baseline.
- •MRI evidence of active axSpA ≤ 6 (ideally ≤ 3) months prior to randomisation using ASAS criteria.
- •Stable NSAID use prior to study entry.
- •Stable use of MTX, sulfasalazine or leflunomide prior to study entry.
- •Stable oral corticosteroid dose prior to study entry.
- •Capable of giving signed informed consent.
- •Inadequately responded to or experienced intolerance to previous treatment with an anti-TNF agent (some subjects).
排除标准
- •Current diagnosis of axSpA with a BASDAI > 4 but no evidence of inflammation on MRI.
- •Discontinued biologic therapy < 8 weeks prior to Baseline.
- •Previous or current use of oral corticosteroid as defined in protocol.
- •Received intra-articular or i.v. corticosteroids prior to or during Screening.
- •Received anti-IL-17A or anti-IL-12/23 therapy.
- •Received cyclosporine, tacrolimus or mycophenolate mofetil prior to Baseline.
- •Previously received stem cell transplantation.
- •Infection(s) requiring treatment with i.v. anti-infectives or oral anti-infectives prior to Baseline.
- •Abnormal screening laboratory and other analyses.
- •Receipt of any live vaccine within 2 weeks prior to randomisation, or will require live vaccination during study participation.
- •Evidence of current or prior dysplasia or history of malignancy.
- •Has had any uncontrolled and/or clinically significant illness, hospitalisation, or any surgical procedure requiring general anaesthesia prior to Screening, or any planned surgical procedure within 6 months after randomisation.
- •Known current or previous interstitial lung disease.
- •Positive pregnancy test at Screening (serum) or Baseline (urine).
- •Female subjects who are breastfeeding or considering becoming pregnant during the study.
- •Considered by the Investigator to be an unsuitable candidate for the study.
- •Received any investigational agent or procedure within 30 days or 5 half-lives prior to Baseline.
- •Related to or a dependent of the site staff, or a member of the site staff.
结局指标
主要结局
The Proportion of Subjects Who Achieved ASAS20 Clinical Response
时间窗: Weeks 12
The primary endpoint was the proportion of subjects who achieved an Assessment in Ankylosing Spondylitis with 20% improvement (ASAS20) clinical response at Week 12. An ASAS20 clinical response was defined as an improvement of at least 20% and an absolute improvement of at least 10 units on a 0 to 100 scale in at least three of the following four domains collected in the electronic case report form (eCRF) and no worsening in the fourth domain: Subject's Global Assessment of Disease Status, Subject's Assessment of Spinal Pain, function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]) and inflammation (last two questions of the BASDAI). Lower values within the individual domains represent less severe symptoms.
次要结局
- Proportion of Subjects Who Achieved Clinically Important ASDAS-CRP Score at Week 12(Week 12)
- Proportion of Subjects Who Achieved an ASAS20 Clinical Response at Week 6(Week 6)
- Proportion of Subjects Who Achieved ASAS40 Clinical Response at Week 12(Week 12)
- Proportion of Subjects Who Achieved Ankylosing Spondylitis Disease Activity Score C-reactive Protein (ASDAS-CRP) Response at Weeks 6(Week 6)