Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Study Overview
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Brief Summary
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The primary objectives of the study are: To evaluate the safety and tolerability of three dose levels of MT-1303 in subjects with moderate to severe chronic plaque psoriasis. To evaluate the efficacy of three doses levels of MT-1303 in subjects with moderate to severe chronic plaque psoriasis compared to placebo after 16 weeks of treatment on Psoriasis Area and Severity Index (PASI).

Official Title
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A Phase IIa, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Conditions
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Plaque Psoriasis

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: Have been diagnosed with plaque psoriasis for at least 6 months prior to screening Have moderate to severe chronic plaque psoriasis as defined by PASI score ≥ 12 and BSA ≥ 10% at baseline In the investigator's opinion is a candidate for systemic therapy Exclusion Criteria: Non-plaque forms of psoriasis (e.g., guttate, erythrodermic or pustular) Current drug-induced or aggravated psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta-blockers, calcium-channel blockers, or lithium carbonate) History of any of a list of pre-defined cardiovascular diseases History or known presence of any significant infectious, metabolic, oncological, ophthalmological or respiratory system disease or illness likely to render the subject unsuitable for the study. Previous exposure to any other S1P receptor modulator Receipt of a live vaccine within 28 days prior to randomisation 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 Clinically significant findings electrocardiogram (ECG) findings.

Ages Eligible for Study
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Minimum Age: 18 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: Double


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 |
| --- | --- | --- |
| Proportion of subjects who achieve PASI 75 (at least 75% reduction from baseline) |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, Plaque Psoriasis