jRCT2071240089招募中不适用
A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults with Moderate to Severe Sjogren's Disease (SjD) (DAFFODIL )
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 主要终点
- Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening
- •Meets criteria for diagnosis of SjD by the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria
- •Seropositive for antibodies to Ro/SSAA (Ro60 and/or Ro52) at screening
- •Total ClinESSDAI score greater than or equal to (>=) 5 at screening
- •Participants of childbearing potential must have a negative highly sensitive serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to randomization
排除标准
- •Has a history of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary,cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder or clinically significant abnormalities in screening laboratory
- •Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients or excipients used in the placebo formulation
- •Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her SjD or has a family history of congenital or hereditary immunodeficiency
- •Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins (for example [e.g.], monoclonal antibodies, intravenous immunoglobulin)
- •Has any unstable or progressive manifestation of SjD that is likely to warrant escalation in therapy beyond permitted background medications
结局指标
主要结局
Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48
时间窗: Baseline to Week 48
ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD. The ClinESSDAI includes 11 domains divided into 3-4 activity levels, where zero represents no activity and low, medium, and high scores can vary in numerical value depending on the domain being measured. A higher score represents worse disease symptoms.
次要结局
- Improvement from Baseline in Minimal Clinically Important Improvement (MCII) in ClinESSDAI Score at Week 48(Baseline to Week 48)
- Improvement from Baseline in ClinESSDAI Score at Week 48 in Participants with High Immunoglobulin (IgG) Levels at Baseline(Baseline to Week 48)
- Change from Baseline in ClinESSDAI Score at Week 8(Baseline to Week 8)
- Change from Baseline in Stimulated Salivary Flow Rate at Week 48(Baseline to Week 48)
- Change from Baseline in Sjogren's Symptoms Dryness Score at Week 48(Baseline to Week 48)
- Change from Baseline in Sjogren's Symptoms Joint Pain Score at Week 48(Baseline to Week 48)
- Change from Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) Score At Week 48(Baseline to Week 48)
- Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) Fatigue Score at Week 48(Baseline to Week48)
研究者
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