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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01987843

Enrollment

142

Registered

2013-11-19

Start date

2013-09-30

Completion date

2014-11-30

Last updated

2014-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

Keywords

Psoriasis, Plaque Psoriasis

Brief summary

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).

Interventions

DRUGMT-1303-Low

DRUGMT-1303-Middle

DRUGMT-1303-High

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Proportion of subjects who achieve PASI 75 (at least 75% reduction from baseline)	16 weeks

Countries

Bulgaria, Estonia, Germany, Hungary, Latvia, Poland, Russia, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026