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

Mitsubishi Tanabe Pharma Corporation1 site in 1 country142 target enrollmentSeptember 2013

Overview

Phase: Phase 2
Intervention: MT-1303-Low
Conditions: Plaque Psoriasis
Sponsor: Mitsubishi Tanabe Pharma Corporation
Enrollment: 142
Locations: 1
Primary Endpoint: Proportion of subjects who achieve PASI 75 (at least 75% reduction from baseline)
Status: Completed
Last Updated: 11 years ago

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).

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

November 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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.