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May 4, 2021, 2:30 a.m. eu

Participants are excluded from the study if any of the following criteria apply: 1. Recent history of severe cardiovascular disease including acute myocardial infarction, unstable angina pectoris, coronary revascularization procedure, congestive heart failure of NYHA Class III or IV, stroke, including a transient ischemic attack, edema of cardiac origin and left ventricular ejection fraction ≤ 50%, prolongation of the congenital or acquired QT interval. 2. Patient who had major surgery within 2 weeks prior to screening visit. 3. Patient with known hypersensitivity to masitinib or to any of theirs excipients 4. Patient with severe hepatic impairment defined as hepatic transaminase levels > 5 ULN or total bilirubin level > 1.5 ULN 5. Patient with severe renal impairment defined as a glomerular filtration rate < 30 ml/min/1.73 m2. 6. Patient on treatment for malignancy or with a history of cancer in the preceding 5 years, except adequately treated non-melanoma skin cancer. 7. Patient with atopic disease 8. Concomitant use of strong inducer of CYP3A4, substrate of CYP3A4 with narrow therapeutic index. 9. Concomitant treatment with CYP2C8 inhibitors 10. Patient with concomitant treatment or therapies associated with severe drug-induced skin toxicity. 11. Patient unable to swallow oral treatments 12. Pregnancy and lactation. 13. Patient with any of following laboratory results out of the ranges detailed below at screening should be discussed depending of the medication: Absolute neutrophils count (ANC) ≤ 1.5 x 109/L Haemoglobin ≤ 10 g/dL Platelets (PLT) ≤ 100 x 109/L Albuminemia ≤ 1 x LLN 14. Patient with any condition that the physician judges could be detrimental to patient participating in this study, including any clinically important deviations from normal clinical laboratory values or concurrent medical conditions. 15. Patient enrolled in any other therapeutic clinical trial with the same endpoints. 16. Absence of Social Security 17. Patient protected by law under guardianship or curatorship

Participants are excluded from the study if any of the following criteria apply: 1. Recent history of severe cardiovascular disease including acute myocardial infarction, unstable angina pectoris, coronary revascularization procedure, congestive heart failure of NYHA Class III or IV, stroke, including a transient ischemic attack, edema of cardiac origin and left ventricular ejection fraction ≤ 50%, prolongation of the congenital or acquired QT interval. 2. Patient who had major surgery within 2 weeks prior to screening visit. 3. Patient with known hypersensitivity to masitinib or to any of theirs excipients 4. Patient with severe hepatic impairment defined as hepatic transaminase levels > 5 ULN or total bilirubin level > 1.5 ULN 5. Patient with severe renal impairment defined as a glomerular filtration rate < 30 ml/min/1.73 m2. 6. Patient on treatment for malignancy or with a history of cancer in the preceding 5 years, except adequately treated non-melanoma skin cancer. 7. Patient with atopic disease 8. Concomitant use of strong inducer of CYP3A4, substrate of CYP3A4 with narrow therapeutic index. 9. Concomitant treatment with CYP2C8 inhibitors 10. Patient with concomitant treatment or therapies associated with severe drug-induced skin toxicity. 11. Patient unable to swallow oral treatments 12. Pregnancy and lactation. 13. Patient with any of following laboratory results out of the ranges detailed below at screening should be discussed depending of the medication: Absolute neutrophils count (ANC) ≤ 1.5 x 109/L Haemoglobin ≤ 10 g/dL Platelets (PLT) ≤ 100 x 109/L Albuminemia ≤ 1 x LLN 14. Patient with any condition that the physician judges could be detrimental to patient participating in this study, including any clinically important deviations from normal clinical laboratory values or concurrent medical conditions. 15. Patient enrolled in any other therapeutic clinical trial with the same endpoints. 16. Absence of Social Security 17. Patient protected by law under guardianship or curatorship

Oct. 26, 2020, 7:26 a.m. eu

Participants are excluded from the study if any of the following criteria apply: 1. Recent history of severe cardiovascular disease including acute myocardial infarction, unstable angina pectoris, coronary revascularization procedure, congestive heart failure of NYHA Class III or IV, stroke, including a transient ischemic attack, edema of cardiac origin and left ventricular ejection fraction ≤ 50%. 2. Patient who had major surgery within 2 weeks prior to screening visit. 3. Concomitant use of strong inducer of CYP3A4, substrate of CYP3A4 with narrow therapeutic index. 4. Concomitant treatment with anti-viral drugs, anti-interleukins, anti-interleukins receptors, any investigational drugs 5. Patient with concomitant treatment or therapies associated with severe drug-induced skin toxicity. 6. Pregnancy and lactation. 7. Patient with any of following laboratory results out of the ranges detailed below at screening should be discussed depending of the medication: Absolute neutrophils count (ANC) ≤ 1.5 x 109/L Haemoglobin ≤ 10 g/dL Platelets (PLT) ≤ 100 x 109/L Albuminemia ≤ 1 x LLN 8. Patient with any condition that the physician judges could be detrimental to patient participating in this study, including any clinically important deviations from normal clinical laboratory values or concurrent medical conditions.

Participants are excluded from the study if any of the following criteria apply: 1. Recent history of severe cardiovascular disease including acute myocardial infarction, unstable angina pectoris, coronary revascularization procedure, congestive heart failure of NYHA Class III or IV, stroke, including a transient ischemic attack, edema of cardiac origin and left ventricular ejection fraction ≤ 50%. 2. Patient who had major surgery within 2 weeks prior to screening visit. 3. Concomitant use of strong inducer of CYP3A4, substrate of CYP3A4 with narrow therapeutic index. 4. Concomitant treatment with anti-viral drugs, anti-interleukins, anti-interleukins receptors, any investigational drugs 5. Patient with concomitant treatment or therapies associated with severe drug-induced skin toxicity. 6. Pregnancy and lactation. 7. Patient with any of following laboratory results out of the ranges detailed below at screening should be discussed depending of the medication: Absolute neutrophils count (ANC) ≤ 1.5 x 109/L Haemoglobin ≤ 10 g/dL Platelets (PLT) ≤ 100 x 109/L Albuminemia ≤ 1 x LLN 8. Patient with any condition that the physician judges could be detrimental to patient participating in this study, including any clinically important deviations from normal clinical laboratory values or concurrent medical conditions.