EUCTR2021-000639-30-GR进行中（未招募）1 期
A 96-Week, Prospective, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/day versus Placebo in the Treatment of Patients with Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse.
AB Science0 个研究点目标入组 800 人开始时间: 2022年2月4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
- 800
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
- •A patient must fulfill all of the following inclusion criteria to be eligible to participate in the study:
- •1.Male or female patients aged between 18 and 65 years at screening (both inclusive)
- •2.Weight >45 kg and BMI between 18 and 35 kg/m2 at screening or at baseline
- •3.Patients with either primary progressive or secondary progressive multiple sclerosis with onset of symptoms at least five years before baseline and with no relapse diagnosed according to the 2017 revised McDonald’s criteria at least two years before screening
- •4.Patients with Expanded Disability Status Scale (EDSS) score between 3.0 to 6.0 (both inclusive) at screening and baseline
- •5.Patients with an EDSS score progression =1 point with no improvement during 2 years before screening
- •6.Absence of T1 Gadolinium-enhancing brain lesions at baseline as measured by MRI
- •7.Contraception to be assessed at screening and at baseline::
- •-Female patients of childbearing potential (entering the study after a menstrual period and who has a negative pregnancy test), who agrees to use a highly effective method of contraception and an effective method of contraception by her male partner during the study and for 3 months and a half after the last treatment intake
- •-Male patients with a female partner of childbearing potential who agrees to use a highly effective method of contraception and an effective method of contraception by his female partner during the study and for 3 months and a half after the last treatment intake OR who agrees to use an effective method of contraception and a highly effective method of contraception by his female partner during the study and for 3 months and a half after the last treatment intake
- •Highly effective and effective methods of contraception are detailed in the appendix 14.1 of the protocol.
- •8.Patient able to understand, and willing to sign, and date the written informed consent form prior to any protocol-specific procedures. If patients are duly capable of study consent but are unable to sign by themselves due to aggravation of disease condition, written informed consent can be obtained from a legally authorized representative who can sign on behalf of the patients after confirming the patients' agreement to study participation
- •9.Patient able and willing to comply with study protocol and to come on-site as per protocol visits schedule, assessed at screening and at baseline.
- •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 800
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients suffering from a disease other than MS that would better explain the patient’s neurological clinical signs&symptoms and/or MRI lesions observed at screening
- •2.Inability to complete MRI(contraindications for MRI)and/or any known allergy or hypersensitivity or any contra-indication to gadolinium macrocyclic
- •3.Patients treated with other disease modifying treatments in the time frames and conditions mentioned under previous treatment wash out period, assessed at baseline
- •4.Patients with lymphocytes<1.0×109/L at screening&at baseline
- •5.Patients with hypersensitivity to masitinib or its excipients at screening
- •6.Patients with history(or family history)of severe skin toxicities or reactions at screening or patients taking concomitant treatment or therapies associated with severe drug-induced skin toxicity at screening&baseline
- •7.Patients with history of severe bone marrow disorders such as agranulocytosis or aplasia,or with abnormal laboratory results at screening&baseline defined as: -Neutropenia withANC<1.5×109/L -Anemia withHgb<10g/dl -Thrombocytopenia with platelet counts<75×109/L
- •8.Patients with history of severe hepatic disorders, such as viral hepatitis or steatohepatitis,and alcohol steatosis,or with abnormal laboratory results defined as: -Hepatic transaminase levels>2ULN at baseline,or -Total bilirubin level>1.5ULN at baseline, or -Both hepatic transaminase levels&total bilirubin level outside of the normal ranges at screening&baseline,or -Albuminemia<1×LLN at screening and baseline, or -Patients with concomitant medication known to be associated severe hepatotoxicity
- •9.Patients with pre-existing severe renal impairment, or with abnormal laboratory results at screening:
- •-Creatinine clearance<60 mL/min(Cockcroft&Gault formula)or -Proteinuria>30 mg/dL(1+)on dipstick in case of the proteinuria=1+ on the dipstick, 24h proteinuria must be>1.5g/24h
- •10.Patients with current or history of severe cardiovascular disease,assessed at screening:-Myocardial infarction -Unstable angina pectoris -Coronary revascularization procedure -Congestive heart failure ofNYHA ClassIIIorIV - Stroke,including a transient ischemic attack -2nddegree or3rd-degree atrioventricular block not successfully treated with a pacemaker Bi-fascicular block -QTc Fridericia interval>450milliseconds for males&>470milliseconds for females -Drug induced heart failure or ischemic heart disease -Radiotherapy induced cardiomyopathy -Family history of unexpected death of cardiovascular origin -Edema of cardiac origin&left ventricular ejaculation fraction=50%
- •11.Patients, with two or more of the risk factors listed below assessed by a cardiologist at screening as Very High Risk(calculated SCORE*=10%.)or High Risk(calculated SCORE*=5% &<10%)according to the Systematic Coronary Risk Estimation(SCORE):-Hypertension (uncontrolled) -Diabetes -Kidney disease -Current tabagism(=10Pack-year:equivalent to1pack of20cigarettes for10years with the formulaN(number of packs of20cigarettes smoked daily)×T(number years smoking))Patients who stopped smoking6months prior to the evaluation,are not concerned -Hypercholesterolemia, -Chronic obstructive pulmonary disease(COPD)
- •*This assessment is done according to the Systematic Coronary Risk Estimation(SCORE)using the country specific free full version of HeartScore®,the interactive tool for predicting and managing the risk of heart attack and stroke in Europe, available at https://www.heartscore.org/en_GB/access
- •If the country specific
研究者
相似试验
进行中（未招募）
1 期
A phase 3 study to compare efficacy and safety of masitinib with placebo in the patients with primary progressive or secondary progressive multiple sclerosis without relapse.Patients with primary progressive or secondary progressive multiple sclerosis without relapseMedDRA version: 21.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2021-000639-30-DEAB Science800
进行中（未招募）
1 期
A phase 3 study to compare efficacy and safety of masitinib with placebo in the patients with primary progressive or secondary progressive multiple sclerosis without relapse.Patients with primary progressive or secondary progressive multiple sclerosis without relapseMedDRA version: 21.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2021-000639-30-ESAB Science800
进行中（未招募）
3 期
2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib versus placebo in the treatment of primary progressive or relapse-free secondary progressive multiple sclerosisCTRI/2016/09/007268AB Science1
进行中（未招募）
不适用
A 96 weeks study to compare efficacy and safety of masitinib to placebo in the treatment of patients with primary progressiveor relapse free secondary progressive multiple sclerosisPrimary progressive or relapse-free secondary progressive multiple sclerosisMedDRA version: 16.0Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 16.0Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2010-021219-17-PLAB Science450
进行中（未招募）
1 期
A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosisEUCTR2010-021219-17-BGAB Science600