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临床试验/EUCTR2021-000639-30-ES
EUCTR2021-000639-30-ES进行中（未招募）1 期

A 96-Weeks, 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: 2021年9月20日最近更新:
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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
研究概览入排标准研究者记录与标识符相似试验

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 fulfil 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 baseline (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 inclusion and with no relapse diagnosed according to the 2017 revised McDonald’s criteria at least two years before inclusion
  • •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 inclusion
  • •6.Absence of T1 Gadolinium-enhancing brain lesions at baseline as measured by MRI
  • •7.Patients able to understand, and willing to follow the safety procedures mentioned on the patient card in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity
  • •8.Contraception:
  • •-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 2 weeks 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 2 weeks after the last treatment intake
  • •Highly effective and effective methods of contraception are detailed in the appendix 14.1 of the protocol.
  • •9.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
  • •10.Patient able and willing to comply with study protocol and to come on-site as per protocol visits schedule
  • •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 and symptoms and/or MRI lesions
  • •2.Inability to complete MRI (contraindications for MRI) and/or any known allergy or hypersensitivity or any contra-indication to gadolinium macrocyclic
  • •3.Patients with hypersensitivity to masitinib or its excipients
  • •4.Patients with history (or family history) of severe skin toxicities or reactions
  • •5.Patients with history of severe bone marrow disorders such as agranulocytosis or aplasia, or with abnormal laboratory results from local laboratory assessments at screening and baseline defined as:
  • •-Neutropenia with ANC <1.5 × 109/L
  • •-Anemia with Hgb -Thrombocytopenia with platelet counts <150 × 109/L
  • •-Lymphocyets <1.0 × 109/L
  • •6.Patients with history of hepatic disorders, with a known liver disease or recent alcohol abuse, or with abnormal laboratory results from local laboratory assessments defined as:
  • •-Hepatic transaminase levels >2 ULN at baseline, or
  • •-Total bilirubin level >1.5 ULN at baseline, or
  • •-Both hepatic transaminase levels and total bilirubin level outside of the normal ranges at screening and baseline, or
  • •-Albuminemia <1 × LLN at screening and baseline
  • •7.Patients with pre-existing severe renal impairment, or with abnormal laboratory results from local laboratory assessments at screening:
  • •-Creatinine clearance <60 mL/min (Cockcroft and Gault formula) or
  • •-Proteinuria >30 mg/dL (1+) on dipstick; in case of the proteinuria =1+ on the dipstick, 24 hours proteinuria must be >1.5 g/24 hours
  • •8.Patients with current or history of severe cardiovascular disease:
  • •-Myocardial infarction
  • •-Unstable angina pectoris
  • •-Coronary revascularization procedure
  • •-Congestive heart failure of NYHA Class III or IV
  • •-Stroke, including a transient ischemic attack
  • •-Second degree or third-degree atrioventricular block not successfully treated with a pacemaker
  • •-Bi-fascicular block
  • •-QTc Fridericia interval > 450 milliseconds for males and > 470 milliseconds 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 and left ventricular ejaculation fraction =50%
  • •9.Patients, with two or more of the risk factors listed below assessed by a cardiologist as Very High Risk (calculated SCORE* =10%.) or High Risk (calculated SCORE* =5% and <10%) according to the Systematic Coronary Risk Estimation (SCORE*):
  • •-Hypertension (uncontrolled)
  • •-Kidney disease
  • •-Current tabagism (= 10 Pack-year: equivalent to 1 pack of 20 cigarettes for 10 years with the formula N (number of packs of 20 cigarettes smoked daily) × T (number years smoking)) Patients who stopped smoking 6 months prior to the evaluation, are not concerned.
  • •-Hypercholesterolemia,
  • •* 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 version is not available, EU one should be used.
  • •10.Patients with active severe infection such as tuberculosis, viral hepatitis, human immunodeficiency virus infection, syphilis or COVID-19 (confirmed by positive RT-PCR and/or other applicable methods)

研究者

发起方
AB Science

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