Dose-finding Study of MT-1303
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
What it found
The main measure showed a statistically significant benefit.
“Amiselimod 0·2 mg and 0·4 mg significantly reduced the total number of gadolinium-enhanced T1-weighted lesions.”Read by software from the paper's abstract
Total number of gadolinium-enhanced T1-weighted lesions on monthly brain MRI scans from weeks 8 to 24 · weeks 8 to 24
| Group | n | Value |
|---|---|---|
| Placebo | 103 | median 1.6 lesions [range 0-132] |
| Amiselimod 0·1 mg | 105 | median 2.0 [0-105] |
| Amiselimod 0·2 mg | 103 | median 0.0 lesions [range 0-35] |
incident rate ratio vs placebo (0·4 mg) 0.23
p = <0.0001 (0.4 mg); p=0.0001 (0.2 mg); p=0.7517 (0.1 mg, median difference)
Total participants: 415
Read by software from the paper's abstract
What was tested
Treatment tested
- Amiselimod
- MT-1303-Middle
Placebo
- Placebo
What it measured
Main measures
The total number of MRI Gd-enhanced T1-weighted lesions
Weeks 24
MRI lesions• Total number of monthly MRI Gd-enhanced T1-weighted lesions observed across post-baseline visits (Weeks 8-24)
MRI lesions
Other measures (1)
• Total number of monthly MRI Gd-enhanced T1-weighted lesions observed across all scheduled post-baseline visits (Weeks 4-24)
MRI lesions
Who could take part
Relapsing MS · 18 to 60
Show the full criteria
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Two-year results from a phase 2 extension study of oral amiselimod in relapsing multiple sclerosis.Mult Scler · 2018
Results
Safety and efficacy of amiselimod in relapsing multiple sclerosis (MOMENTUM): a randomised, double-blind, placebo-controlled phase 2 trial.Lancet Neurol · 2016
Amiselimod 0·2 mg and 0·4 mg significantly reduced the total number of gadolinium-enhanced T1-weighted lesions.
Read by software from the paper's abstract
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History
Started
Jan 2013
Main results due
Jul 2014
Finished
Oct 2014