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OpenTrials
Completed

NCT Number: NCT01987843

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

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Dupnitsa, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MT-1303-Low

Drug

MT-1303-Middle

Drug

MT-1303-High

Drug

Placebo

Drug

Primary outcomes

  1. Proportion of subjects who achieve PASI 75 (at least 75% reduction from baseline)

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 19, 2013
Registry last updated
Dec 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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