Phase II Clinical Trial of OCH-NCNP1

Study Overview
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Brief Summary
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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) .

Official Title
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Efficacy and Safety of OCH-NCNP1 in Patients With Relapsing Multiple Sclerosis

Conditions
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Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive

Intervention / Treatment
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* Drug: OCH-NCNP1
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject with Multiple Sclerosis eligible for enrolment in the study must meet all of the following criteria: Provision of written informed consent to participate in this study Patients diagnosed as relapsing remitting multiple sclerosis based on modified McDonald criteria in 2017 Relape must have been confirmed by a neurologist at least twice within 24 months, or once within 12 months before enrollment Have at least one T2 lesion on MRI scans at screening EDSS less than or equal to 7 20 =< Age < 65 Promise to prevent conception for at least 90 days after the last administration 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: Diagnosed as Neuromyelitis Optica Women who are pregnant or lactating Patients who is prohibited MRI Patients who are allergic to Gd-contrast medium History of liver diseases or liver transplantation Liver dysfunction in the screening test and baseline physical examination History of cancer past five years Negative for herpes zoster virus antibody Positive for Syphilis serum reaction Positive for Beta-glucan or positive for T-spot Positive for Anti-Aquaporin 4 antibody History of HIV infection History of HBV or HCV infection History of Transplantation Use of any other investigational agents and/or experimental agents within 4 months prior to the first anticipated administration of study medication. History of blood donation (200 ml within 2 months, 400 ml within 3 months) prior to the first anticipated administration of study medication Lymphocyte number < 600 /mm3 in peripheral blood Current diagnosed or suspected infectious diseases Compromised Patients Inflammatory Bowel disease Subjects with prolongation of QT/QTc interval History or have risk of torsade de pointes Taking the medicine which has risk of prolongation of QT/QTc interval History of severe allergy of medicine or food History or current of drug/ alcohol addiction Bronchial Asthma Epilepsy Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OCH-NCNP1 3 mg<br> | Drug: OCH-NCNP1<br>* OCH-NCNP1 3mg is supplied as granules and take orally once a week.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo is supplied as granules and take orally once a week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of the patients who identified new or enlarging T2 lesions on MRI scans compared to baseline |  | Change from screening at Month 6. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| annual relapse rate |  | Month 6 | 
| Detection of asymptomatic |  | Month 6 | 
| Expanded Disability Status Scale (EDSS) / Functional Scale (FS) |  | screening, 4weeks, 8 weeks, 12 weeks, 16weeks, 20 weeks, 24 weeks | 
| Duration of sustained reduction in disability (SRD) |  | Month 6 | 
| Change of MRI |  | Change from screening at Month 3 and 6 | 
| Change of No evidence of disease activity (NEDA) |  | Change from screening at Month 3 and 6 |