EUCTR2019-000906-31-DE进行中（未招募）1 期
A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age =18 years (male or female) at time of providing written informed consent
- •2. Documented diagnosis of dcSSc according to ACR / EULAR criteria 2013
- •3. mRSS = 15 and = 45
- •4. Disease duration = 5 years defined as the time from the first non-Raynaud’s phenomenon manifestation
- •5. Subjects within first 18 months of disease duration from first non-Raynaud’s phenomenon manifestation. For those >18 to = 60 months, subjects with worsening of sclerodermatous skin involvement in one or more body areas (including any new areas of involvement) within 6 months prior to Screening and/or the presence of a tendon friction rub within 3 months prior to Screening as documented and determined by the investigator
- •based on medical history and medical records
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 144
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Primary rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, and dermatomyositis, as determined by the investigator
- •Note: Subjects with fibromyalgia, secondary Sjogren’s syndrome, and scleroderma-associated myopathy or myositis at Screening are not excluded
- •2. Positive anti-centromere autoantibodies at Screening
- •3. Evidence of severe chronic kidney disease with estimated glomerular filtration rate < 45 mL/min/1.73m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation) or receiving dialysis. Additionally, subjects with current confirmed diagnosis of diabetes mellitus and requiring medication, with eGFR < 90 mL/min/1.73m2 will be excluded from the study.
- •4. History of documented thrombotic episode eg, PE, DVT, myocardial infarction, thromboembolic stroke at any time
- •Note: past superficial thrombophlebitis more than two years from Screening is not exclusionary
- •5. Documented thrombophilic abnormalities including blood hyperviscosity, protein S or protein C deficiency, anti-thrombin-3 deficiency, plasminogen deficiency, antiphospholipid syndrome, Factor V Leiden mutation, dysfibrinogenemia, or prothrombin G20210A mutation
- •6. Greater than 3 specified current risk factors for TEEs (documented and currents conditions): atrial fibrillation, coronary disease, diabetes mellitus, dyslipidemia, hypertension, obesity (Body Mass Index = 30 kg/m2), recent significant trauma, and immobility (wheelchair-bound or bedridden)
- •7. Ongoing active serious infection at Screening (including, but not limited to, pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess)
- •8. Malignancy in the past 2 years, except for non-melanoma skin cancer, cervical carcinoma in situ, or other in situ cancer if it has been excised and treated within in the past year
- •9. Known hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration > 0.2 g/L)
- •10. Known IgA deficiency or serum IgA level < 5% lower limit of normal
- •11. Known or suspected antibodies to the IP, or to excipients of the IP.
研究者
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