Phase II Clinical Trial of OCH-NCNP1
Phase II Clinical Trial of OCH-NCNP1
This study is designed to assess the efficacy and safety of OCH-NCNP1 compared to placebo in
 subjects diagnosed with relapsing remitting multiple sclerosis (RRMS) and secondary
 progressive mltiple sclerosis (SPMS) .
Inclusion Criteria:

 -  Subject with Multiple Sclerosis eligible for enrolment in the study must meet all of
 the following criteria:

 1. Provision of written informed consent to participate in this study

 2. Patients diagnosed as relapsing remitting multiple sclerosis based on modified
 McDonald criteria in 2017

 3. Relape must have been confirmed by a neurologist at least twice within 24 months,
 or once within 12 months before enrollment

 4. Have at least one T2 lesion on MRI scans at screening

 5. EDSS less than or equal to 7

 6. 20 =< Age < 65

 7. Promise to prevent conception for at least 90 days after the last administration

 8. Neurological stability has been confirmed by a neurologist

 Exclusion Criteria:

 -  Subject with MS patients meeting any of the following criteria must not be enrolled in
 the study:

 1. Diagnosed as Neuromyelitis Optica

 2. Women who are pregnant or lactating

 3. Patients who is prohibited MRI

 4. Patients who are allergic to Gd-contrast medium

 5. History of liver diseases or liver transplantation

 6. Liver dysfunction in the screening test and baseline physical examination

 7. History of cancer past five years

 8. Negative for herpes zoster virus antibody

 9. Positive for Syphilis serum reaction

 10. Positive for Beta-glucan or positive for T-spot

 11. Positive for Anti-Aquaporin 4 antibody

 12. History of HIV infection

 13. History of HBV or HCV infection

 14. History of Transplantation

 15. Use of any other investigational agents and/or experimental agents within 4
 months prior to the first anticipated administration of study medication.

 16. History of blood donation (200 ml within 2 months, 400 ml within 3 months) prior
 to the first anticipated administration of study medication

 17. Lymphocyte number < 600 /mm3 in peripheral blood

 18. Current diagnosed or suspected infectious diseases

 19. Compromised Patients

 20. Inflammatory Bowel disease

 21. Subjects with prolongation of QT/QTc interval

 22. History or have risk of torsade de pointes

 23. Taking the medicine which has risk of prolongation of QT/QTc interval

 24. History of severe allergy of medicine or food

 25. History or current of drug/ alcohol addiction

 26. Bronchial Asthma

 27. Epilepsy Other protocol-defined exclusion criteria may apply