EUCTR2021-000639-30-DE进行中（未招募）1 期
A 96-Week, Prospective, Multicenter, Randomised, Double-Blind, PlaceboControlled, 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1月24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
- •Inclusion Criteria
- •Related to disease
- •1. 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
- •2. Patients with Expanded Disability Status Scale (EDSS) score between 3.0 to 6.0 (both inclusive) at screening and baseline
- •3. Patients with an EDSS score progression =1 point with no improvement during 2 years before screening
- •4. Absence of T1 Gadolinium-enhancing brain lesions as measured by MRI at screening
- •Other inclusion criteria
- •5. Male or female patients aged between 18 and 65 years at screening
- •6. Weight >45 kg and BMI between 18 and 35 kg/m2 at screening and baseline
- •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. Patients able to understand, and willing to sign, and date the written informed consent form prior to any protocol-specific procedures, at screening. 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. Patients able and willing to comply with study protocol and to come onsite
- •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 720
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •Exclusion Criteria:
- •Related to disease
- •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 observed at screening
- •2. Inability to complete screening 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 and at baseline
- •Other exclusion criteria
- •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 and baseline
- •7. Patients with history of severe bone marrow disorders such as agranulocytosis or aplasia, or with abnormal laboratory results at screening and baseline defined as:
- •- Neutropenia with ANC <1.5 × 109/L
- •- Anemia with Hgb <10 g/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 >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, or
- •- Patients with concomitant medication known to be associated with severe hepatotoxicity
- •9. Patients with pre-existing severe renal impairment, or with abnormal laboratory results 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
- •10. Patients with current or history of severe cardiovascular disease, assessed
- •at screening:
- •- 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%
- •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% and <10%) according to the Systematic Coronary Risk Estimation (SCORE):
- •- Hypertension (uncontrolled) ; - Diabetes; - 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,
- •- Chronic obstructive pulmonary disease (COPD)
- •* This assessment is done according to
研究者
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