Stwardnienie rozsiane: badanie fazy II leku fenebrutinib

Kryteria wyłączenia kto nie może wziąć udziału (14)

1. A diagnosis of primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS)
2. Co-morbid Conditions:
3. Potentially confounding neurological, somatic, or metabolic disorders
4. Current clinically significant psychiatric or medical illness
5. History of cancer, transplants, or bleeding disorders
6. Inability to complete an MRI scan or get gadolinium
7. Abnormal liver function tests or blood counts
8. Sensitivity or intolerance to any ingredient (including excipients) of fenebrutinib tablets
9. Active, recurrent, or chronic infections
10. Recent or anticipated use of prohibited medications/treatments:
11. Certain disease-modifying therapy (DMT) and other immunosuppressants
12. Drugs interacting with fenebrutinib (Cytochrome P450 3A4 [CYP3A4] inhibitors)
13. Any other investigational therapy, anticoagulants, certain vaccines
14. A score of 4 or 5 on the "last 6 months" section of the screening SI section or "yes" on any item of the "last 6 months" Suicidal Behavior (SB) section of the C-SSRS or a positive answer on Question 9 of the Patient Health Questionnaire-9 Modified for Adolecents (PHQ-A) or significant risk of suicide, in the investigator's judgment