EUCTR2016-001028-80-BE进行中（未招募）1 期
Efficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 94
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
入选标准
- •-Systemic Sclerosis according to the American College of Rheumatology/The European League against Rheumatism (ACR/EULAR) 2013 criteria.
- •-Diffuse cutaneous form of SSc according to Leroy’s criteria.
- •-Able and willing to sign the written informed consent form with comprehension of its contents and comply with the requirements of the study protocol.
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •-Age <18 years of age.
- •-Disease duration of >36 months from time of first non-Raynaud’s phenomenon manifestation.
- •-mRSS <10 or >35 at screening and baseline visits.
- •-History of vasculitis, active or in remission
- •-Diagnosis of connective tissue disease (other than SSc) or overlap syndrome (eg, polymyositis/SSc).
- •-Positive Human Immunodeficiency Virus (HIV) serology or a known history of HIV infection, active or in remission
- •-Abnormal hepatitis B and/or hepatitis C tests indicative of active or chronic infection ((refer to protocol)
- •-Positive or 2 confirmed indeterminate Quantiferon-TB Gold tests at screening
- •-Serious infection (eg, pneumonia, pyelonephritis) within 4 weeks of screening, infection requiring hospitalization or intravenous antibiotics within 4 weeks of screening or chronic bacterial infection (eg, osteomyelitis).
- •-History of anaphylaxis to any biologic therapy.
- •-Evidence of any clinically significant, severe or unstable, acute or chronically progressive, uncontrolled infection or medical condition (eg, cerebral, cardiac, pulmonary, renal, hepatic, gastrointestinal or neurologic other than SSc or SSc-ILD) or previous, active or pending surgical disorder, or any condition that may affect patient safety in the judgment of the Investigator.
- •-At screening, the % predicted forced vital capacity (FVC) is =75% AND % predicted carbon monoxid diffusing lung capacity (DLCO) after hemoglobin correction is =40%
- •-History of heart failure (including acutely decompensated in the setting of preserved ejection fraction), Left Ventricular Ejection Fraction (LVEF) =45%, coronary artery disease, angina, myocardial infarction, ischemic cardiomyopathy and/or hypertrophic cardiomyopathy
- •-Any prior history of malignancy or active malignancy, including lymphoproliferative diseases (except successfully-treated carcinoma in-situ of the cervix, non-metastatic squamous cell or basal cell carcinoma of the skin) within 5 years prior to baseline.
- •Ischemic ECG changes (except those NOT supported by the findings of a left heart catheterization performed in the last year within screening) and/or other clinically significant ECG findings (Appendix L) at screening. (All abnormal ECG finding will be reviewed and confirmed by a local cardiologist.)
- •-High dose steroids (>10 mg/day prednisolone equivalent); or change in steroid dose within 4 weeks prior to screening or during the screening period; or expected changes during the course of the study.
- •-Previous treatment with rituximab within 12 months prior to screening.
- •-Previous treatment with bone marrow transplantation, total lymphoid irradiation or ablative ultrahigh dose cyclophosphamide.
- •-Treatment with high dose immunosuppressive drug (eg, cyclophosphamide >1 mg/kg oral/day or >750 mg IV/month; azathioprine >100 mg/day; methotrexate >15 mg/week; mycophenolate mofetil >2 g/day) within 3 months of screening or change in dose within 4 weeks prior to baseline.
- •-Treatment with etanercept, cyclosporine A, intravenous immunoglobulin (IVIG), rapamycin, Dpenicillamine, tyrosine kinase inhibitors within 4 weeks of screening or antithymocyte globulin within 6 months of screening.
研究者
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