EUCTR2015-001617-27-SI进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Inventiva SA
- 入组人数
- 145
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 ACR/EULAR 2013 criteria
- •Diffuse cutaneous SSc subset (LeRoy’s criteria)
- •Diagnosis within the past 3 years as defined by the first non-Raynaud’s symptom
- •MRSS between 10 and 25
- •Aged between 18 and 75 years
- •Informed consent documented by signature
- •Patients on stable treatment (for >3 months) with prednisone = 10 mg, methotrexate= 20 mg/w, azathioprine = 150 mg/d, mycophenolate mofetil = 2g/d, or leflunomide = 20 mg/d may be included in the study; therapy to be maintained as background therapy
- •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 135
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •Cyclophosphamide during the past 3 months
- •Requirement of IV prostanoids for pulmonary hypertension in the last 3 months
- •Renal insufficiency defined by a creatinine clearance of less than 30ml/min (CKD-EPI or MDRD formula) a and/or past/current renal crisis
- •Hepatic impairment i.e. primary biliary cirrhosis and unexplained persistent liver function abnormality,
- •Gallbladder disease (Cholelithiasis is not an exclusion criterion)
- •Diabetic ketoacidosis
- •Severe cardiac (LVEF <45%) and/or pulmonary disease (FVC < 50% or pulmonary hypertension proven by right heart catheterisation)
- •History of heart failure, symptomatic coronary artery disease, significant ventricular tachyarrhythmia, stent placement, coronary artery bypass surgery, and/or myocardial infarction.
- •Recipient of solid organ transplant
- •Gastrointestinal involvement preventing oral administration of study drug
- •Chronic infections, positive serology for infection with hepatitis B or C.
- •Pregnancy, Lactation. Woman of childbearing potential unwilling to use a medically acceptable form of birth control. Such methods include:
- •- combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
- •- progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
- •- intrauterine device (IUD)
- •- intrauterine hormone-releasing system ( IUS)
- •- bilateral tubal occlusion
- •- vasectomised partner
- •History of malignancy within the last 5 years, except for resected basal or squamous cell carcinoma of the skin, treated cervical dysplasia, or treated in situ cervical cancer
- •A recent history of alcohol or drug abuse, non-compliance with other medical therapies
- •Participation in a clinical study involving another investigational drug or device within the past 4 weeks or during the study
- •Laboratory parameters at the pre-treatment visit showing any of the following abnormal results: transaminases > 2x the upper limit of normal (ULN) and/or bilirubin > 2x ULN; neutrophil count < 1,500/mm3; platelet count < 100,000/mm3; haemoglobin < 9 g/dL
- •known hypersensitivity or allergy to class of drugs or the investigational product
- •Any condition or treatment, which in the opinion of the investigator, places the subject at unacceptable risk as a patient in the trial
- •Co-therapy with biologics. Wash-out period: Any anti-TNF agent in the last 3-months: adalimumab, certolizumab, etanercept, golimumab,
- •infliximab, abatacept and tocilizumab in the last 3 months; rituximab in the last 6 months
- •Any other significant heart disease or any clinically significant ECG abnormality reported by central ECG reading
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