Dose-finding Study of MT-1303

Study Overview
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Brief Summary
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The primary objectives of the study are: To evaluate the effects of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on MRI parameters To evaluate the safety and tolerability of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with RRMS.

Official Title
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A Phase II, Multicentre, Randomised, Double-blind,Parallel Group, Placebo-controlled, Dose-finding Study to Evaluate the Safety and Efficacy of Three Different Oral Doses of MT-1303 Administered for a Period of 24 Weeks in Subjects With Relapsing-remitting Multiple Sclerosis

Conditions
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Relapsing-remitting Multiple Sclerosis

Intervention / Treatment
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* Drug: MT-1303-Low
* Drug: MT-1303-Middle
* Drug: MT-1303-High
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: RRMS as defined by the revised McDonald criteria Evidence of recent MS activity defined as either: at least one documented relapse in the previous 12 months, OR a positive gadolinium (Gd)-enhanced MRI scan within 3 months prior to screening, OR at least two documented relapses in the previous 24 months with a positive Gd-enhanced MRI scan within the previous 12 months Expanded Disability Status Score (EDSS) score ≥0.0 and ≤5.5 points. Exclusion Criteria: Primary progressive, secondary progressive or progressive relapsing MS at screening Disease duration >15 years combined with an EDSS score ≤2.0 Relapse of MS during the Screening Period History or known presence of other neurological disorders likely to render the subject unsuitable for the study History of any of a list of pre-defined cardiovascular diseases History or known presence of any significant central nervous system, infectious, metabolic, oncological, ophthalmological or respiratory system disease or illness likely to render the subject unsuitable for the study Previous exposure to any sphingosine 1-phosphate receptor modulator Receipt of a live vaccine or systemic corticosteroid use within 28 days prior to randomisation Previous treatment with beta-interferons or glatiramer acetate within 14 days prior to randomisation Previous treatment with intravenous immunoglobulin, plasmapheresis, certain immunosuppressants, lymphocyte-depleting therapy, total body irradiation or bone marrow transplantation Need, or likely need for, treatment with Class I or III anti-arrhythmic drugs or with heart-rate-lowering beta-blockers or calcium-channel blockers, or with any other drugs which can reduce the heart rate Evidence of significant anaemia, thrombocytopenia, leucopoenia or lymphocytopenia, renal or hepatic impairment Clinically significant electrocardiogram (ECG) findings.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: MT-1303-Low<br>MT-1303-Low Dose | Drug: MT-1303-Low<br> <br> |
| Experimental: MT-1303-Middle<br>MT-1303-Middle Dose | Drug: MT-1303-Middle<br> <br> |
| Experimental: MT-1303-High<br>MT-1303-High Dose | Drug: MT-1303-High<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total number of MRI Gd-enhanced T1-weighted lesions |  | Weeks 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relapsing-remitting multiple sclerosis, RRMS