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COMPLETEDPHASE2

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

NCT01987843•Tanabe Pharma Corporation

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 65 years

Sex

ALL

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.

Locations (52)

Research Site

Dupnitsa, Bulgaria

Research Site

Pleven, Bulgaria

Research Site

Sofia, Bulgaria

Research Site

Tallinn, Estonia

Research Site

Tartu, Estonia

Research Site

Bavaria, Germany

Research Site

Cologne, Germany

Research Site

Düsseldorf, Germany

Research Site

Essen, Germany

Research Site

Gera, Germany

Key Dates

Start Date

September 1, 2013

Primary Completion Date

September 1, 2014

Completion Date

November 1, 2014

Last Updated

December 18, 2014

Enrollment

142

ACTUAL participants

Conditions

Plaque Psoriasis

Interventions

MT-1303-Low

DRUG

MT-1303-Middle

DRUG

MT-1303-High

DRUG

Placebo

DRUG

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Plaque Psoriasis

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RECRUITINGPHASE2

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

NCT07449702

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis