Relapsing-Remitting Multiple Sclerosis MedDRA version: 15.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: MT-1303
Product Code: MT-1303
Pharmaceutical Form: Capsule
INN or Proposed INN: MT-1303
Current Sponsor code: MT-1303
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
Mitsubishi Tanabe Pharma Corporation (MTPC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. RRMS as defined by the revised McDonald criteria 2. 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 3. Expanded Disability Status Score (EDSS) score =0.0 and =5.5 points. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Primary progressive, secondary progressive or progressive relapsing MS at screening 2. Disease duration >15 years combined with an EDSS score =2.0 3. Relapse of MS during the Screening Period 4. History or known presence of other neurological disorders likely to render the subject unsuitable for the study 5. History of any of a list of pre-defined cardiovascular diseases 6. 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 7. Previous exposure to any sphingosine 1-phosphate receptor modulator 8. Receipt of a live vaccine or systemic corticosteroid use within 28 days prior to randomisation 9. Previous treatment with beta-interferons or glatiramer acetate within 14 days prior to randomisation 10. Previous treatment with intravenous immunoglobulin, plasmapheresis, certain immunosuppressants, lymphocyte-depleting therapy, total body irradiation or bone marrow transplantation 11. 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 12. Evidence of significant anaemia, thrombocytopenia, leucopoenia or lymphocytopenia, renal or hepatic impairment 13. Clinically significant electrocardiogram (ECG) findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To evaluate the effects of MT-1303 compared to placebo on clinical outcomes • To explore the dose-response relationship of three dose levels of MT-1303 in subjects with RRMS • To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of MT-1303 and its phosphorylated metabolite (MT-1303-P) in subjects with RRMS • To evaluate the effects of MT-1303 compared to placebo on quality of life as measured by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) • To obtain deoxyribonucleic acid (DNA) for exploratory purposes (optional).;Main Objective: To evaluate the safety, tolerability and 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. ;Primary end point(s): • Total number of monthly MRI Gd-enhanced T1-weighted lesions observed across post-baseline visits (Weeks 8-24);Timepoint(s) of evaluation of this end point: Various timepoints throughout the study - please refer to the detailed Time and Events Schedule in the protocol for full details | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Various timepoints throughout the study - please refer to the detailed Time and Events Schedule in the protocol for full details;Secondary end point(s): • Total number of monthly MRI Gd-enhanced T1-weighted lesions observed across all scheduled post-baseline visits (Weeks 4-24) • Total number of and volume of new or enlarged T2-weighted lesions observed across all scheduled post-baseline visits (Weeks 4-24) • Change from baseline in brain volume at Week 24 • Exploratory Magnetisation Transfer Ratio (MTR) endpoints detailed in Statistical Analysis Plan (SAP) (selected centres only) • Clinical endpoints o Annualised Relapse Rate (ARR) at Week 24 o Change from baseline in total EDSS score and total Multiple Sclerosis Functional Composite (MSFC) score at Week 24 Pharmacodynamic endpoints: • Lymphocyte counts • Lymphocyte subsets (selected centres only) Safety Endpoints: • Adverse events (AEs) • Vital signs • 12-lead ECG • 3-lead Holter ECG monitoring • Routine safety laboratory assessments • Physical examination • Optical coherence tomography (OCT) Pharmacokinetic Endpoint: • MT-1303 and MT-1303-P concentrations Subject-reported Outcome: • Change from baseline in MSQOL-54 at Week 24. | — |
Countries
Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czech Republic, Finland, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Russian Federation, Serbia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom
Contacts
Public ContactClinical Project Manager
Mitsubishi Pharma Europe Ltd (MPE)
Outcome results
None listed