NCT04605978已完成2 期
A Phase IIa Efficacy and Safety Trial With Intravenous S95011 in Primary Sjögren's Syndrome Patients: An International, Multicentre, Randomised, Double-blind, Placebo-controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 19
- 主要终点
- Change in ESSDAI Total Score
研究概览
简要总结
The purpose of this study is to assess the effect of multiple intravenous infusions of S95011 compared to placebo in reducing disease activity in patients with primary Sjögren's syndrome.
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
- •Diagnosis of primary Sjögren's Syndrome based on 2016 American College of Rheumatology-EULAR criteria
- •ESSDAI total score ≥ 6 during screening, with at least 6 points scored within the 7 following domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, hematologic and biologic,
- •Positive anti-Sjögren's Syndrome A (Ro) antibodies or anti-nuclear antibodies (ANA) ≥ 1:320 or rheumatoid factor (RF) >20 IU/ml during screening period, measured in a central laboratory
- •Stimulated whole salivary flow rate > 0 mL/minute
排除标准
- •Prior administration within the timeframe described in the protocol of any of the following:
- •Belimumab,
- •Rituximab or other B cell depleting agents,
- •Abatacept,
- •Tumor necrosis factor inhibitors,
- •Tocilizumab,
- •Cyclophosphamide,
- •Cyclosporine (except for eye drops), tacrolimus, sirolimus, mycophenolate mofetil (MMF), azathioprine, or leflunomide
- •Janus kinase (JAK) inhibitors
- •Meeting any of the following conditions:
- •Corticosteroids: > 10 mg/day oral prednisone (or equivalent) within 4 weeks prior to randomisation (W000); Any change or initiation of new dose of oral prednisone (or equivalent) within 4 weeks prior to randomisation (W000); Intramuscular, IV, or intra-articular corticosteroids within 4 weeks prior to randomisation (W000); Any change or initiation of new dose of topical corticosteroids within 2 weeks prior to randomisation (W000),
- •Antimalarials: any change or initiation of new dose of antimalarials (e.g. chloroquine, hydroxychloroquine, quinacrine) within 16 weeks prior to randomisation (W000),
- •Methotrexate: > 25 mg/week of methotrexate; any initiation or change of dose of methotrexate within 12 weeks prior to randomisation (W000); any change in route of administration within 4 weeks prior to randomisation (W000),
- •Non-steroidal anti-inflammatory drugs (NSAIDs): Any change or initiation of new dose of regularly scheduled NSAIDs within 2 weeks prior to randomisation (W000),
- •Cevimeline or pilocarpine and cyclosporine eye drops (Restasis) and lifitegrast: any increase or initiation of new doses within 2 weeks prior to randomisation (W000).
- •Secondary Sjögren's Syndrome
研究组 & 干预措施
S95011 concentrate for solution for infusion
Experimental
S95011 is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
干预措施: S95011 concentrate for solution for infusion (Drug)
S95011 Placebo concentrate for solution for infusion
Placebo Comparator
S95011 placebo is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
干预措施: Placebo concentrate for solution for infusion (Drug)
结局指标
主要结局
Change in ESSDAI Total Score
时间窗: From baseline to week 13
Efficacy criterion Eular Sjögren Syndrome Disease Activity index (ESSDAI) is a physician-administered clinical index which has been validated to objectively assess systemic manifestations in Primary Sjögren's Syndrome patients. Scores range from 0 - 123, with a lower score representing less disease activity.
次要结局
- Patient's Global Assessment (PGA) of the Disease Activity(At baseline and week 13)
- ESSDAI Score by Domain and Total Score(At baseline, week 4 and week 13)
- Fatigue (MFI)(At baseline and week 13)
- Physician's Global Assessment (PhGA) of the Disease Activity(At baseline and week 13)
- ESSPRI Score by Symptom and Total Score(At baseline, week 4 and week 13)
- Quality of Life (SF-36)(At baseline and week 13)
- Number of Participants With Adverse Events (AEs)(Through study completion, up to Week 28)
研究者
研究点 (19)
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