EUCTR2016-001028-80-IT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 - NA
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT0 个研究点目标入组 97 人开始时间: 2020年11月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 97
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
- •-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
- •Disease duration>36mths from time of 1nonRaynaud's phenomenon manifestation
- •mRSS<10 or>35 at screen and baseline visits
- •History of vasculitis,active or in remission
- •Diag connective tissue diseases(other than SSc)or PM/Scl
- •Pos HIV serology/known history of HIV active or in remission
- •Abnormal hepB and/or hepC tests indicative active/chronic infection:Abnormal HepB tests:Pos HBsAg OR pos total HBcAb with neg hepB surface Ab(HBsAb)/pos total hepB core antibody with pos HBsAb and presence of hepB DNA(HBV DNA)
- •Abnormal HepC tests:Pos antiHCV Ab and pos HCV RNA
- •Pos or 2confirmed indeterminate QTF tests at screen(regardless of prior treatment status)
- •Serious infection(eg pneumonia, pyelonephritis)within 4wk of screen,infection requiring hospitaliz/IV antibiotics within 4wk of screen or chronic bacterial infection(eg osteomyelitis)
- •History of anaphylaxis to any biologic therapy
- •Evidence of any clinically significant,severe/unstable,acute/chronically progressive,uncontrolled infection or medical condition(eg, cerebral,cardiac,pulmonary,renal,hepatic,gastrointestinal or neurologic other than SSc or SScILD)or previous,active/pending surgical disorder,or any condition that may affect pt safety in the judgment of the PI
- •At screen, the% predicted FVC <=75% AND%predicted DLCO after Hgb correction is<=40%
- •History of HF, LVEF <=45%, coronary artery disease,angina,myocardial infarction,ischemic/HCM
- •Any prior history of malignancy or active malignancy including lymphoproliferative diseases(except successfullytreated carcinoma insitu of the cervix,nonmetastatic squamous cell/basal cell carcinoma of the skin)within 5yrs prior to baseline
- •Ischemic ECG changes and/or other clinical significant ECG findings at screen
- •High dose steroids(>10mg/day prednisolone equiv)or change in steroid dose within 4wk prior to screen or during the screen period or expected changes during the study course
- •Previous treat with rituximab within 12mths prior to screen
- •Previous treat with bone marrow transplantation,tot lymphoid irradiation/ablative ultrahigh dose cyclophosphamide
- •Treat with high dose immunosuppressive drug(eg cyclophosphamide>1mg/kg oral/day or>750mg IV/mth;azathioprine>100mg/day;methotrexate>15mg/week;mycophenolate mofetil>2g/day)within 3mths of screen or change in dose within 4wk prior to baseline
- •Treat with etanercept,cyclosporine A,IVIG,rapamycin,Dpenicillamine,tyrosine K inhibitors within 4wk of screen or antithymocyte globulin within 6mths of screen
- •Treat with infliximab,certolizumab,golimumab,abatacept,or adalimumab,tocilizumab within 8wk of screen or anakinra within 1wk of screen
- •Treat with any IMP within 1mth of screen,or 5halflives,if known Abnormal lab tests at screen:
- •ALT or AST>2 times upper limit of ULN
- •Hgb<11 g/100mL(male) &<10 g/100mL(female)
- •Neutrophils<1500/mm^3(except<1000/mm3 for those of African descent)
- •PLT<100 000/mm^3
- •Creatinine=>150µmol/L
- •Lab parameters may be repeated once during the screen period if felt to be spurious or due to technical error in order to det eligibility
- •Current history of substance and/or alcohol abuse
- •Sanofi current employee/has an immediate family member(eg spouse,parents,child,sibling)Sanofi current employee
- •Currently incarcerated or anticipated/scheduled to be incarcerated during the course of the study
- •Any condition or circumstance that will preclude the pt from following and completing protocol requirements in the opinion of the PI
- •Pregnant or breastfeeding woman
- •Women who are of childbearing potential
研究者
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