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

December 16, 2014 updated by: Mitsubishi Tanabe Pharma Corporation

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Dupnitsa, Bulgaria
        • Research Site
      • Pleven, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
  • Estonia
      • Tallinn, Estonia
        • Research Site
      • Tartu, Estonia
        • Research Site
  • Germany
      • Bavaria, Germany
        • Research Site
      • Cologne, Germany
        • Research Site
      • Duesseldorf, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Gera, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Hanau, Germany
        • Research Site
      • Hessen, Germany
        • Research Site
      • Kiel, Germany
        • Research Site
      • Lubeck, Germany
        • Research Site
      • Mainz, Germany
        • Research Site
  • Hungary
      • Debrecen, Hungary
        • Research Site
      • NyÃ-regyháza, Hungary
        • Research Site
      • Oroshaza, Hungary
        • Research Site
      • Szeged, Hungary
        • Research Site
      • Veszprem, Hungary
        • Research Site
  • Latvia
      • Jelgava, Latvia
        • Research Site
      • Madona, Latvia
        • Research Site
      • Riga, Latvia
        • Research Site
      • Ventspils, Latvia
        • Research Site
  • Poland
      • Bialystok, Poland
        • Research Site
      • Bydgoszcz, Poland
        • Research Site
      • Gdansk, Poland
        • Research Site
      • Katowice, Poland
        • Research Site
      • Lodzkie, Poland
        • Research Site
      • Malopolska, Poland
        • Research Site
      • Olsztyn, Poland
        • Research Site
      • Sroda Wielkopolska, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
      • Wroclaw, Poland
        • Research Site
      • woj. Wielkopolskie, Poland
        • Research Site
  • Russian Federation
      • Chelyabinsk, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • Saint-Petersburg, Russian Federation
        • Research Site
      • Saratovskaya, Russian Federation
        • Research Site
      • Yaroslavl, Russian Federation
        • Research Site
  • Ukraine
      • Dnepropetrovsk, Ukraine
        • Research Site
      • Dniepropetrovsk, Ukraine
        • Research Site
      • Donetskaya, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site
      • Lugansk, Ukraine
        • Research Site
      • Lviv, Ukraine
        • Research Site
      • Odessa, Ukraine
        • Research Site
      • Simferopol, Ukraine
        • Research Site
      • Ternopil, Ukraine
        • Research Site
      • Uzhgorod, Ukraine
        • Research Site
      • Zaporizhzhya, Ukraine
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: MT-1303-Low
MT-1303-Low Dose
Drug: MT-1303-Low
Experimental: MT-1303-Middle
MT-1303-Middle Dose
Drug: MT-1303-Middle
Experimental: MT-1303-High
MT-1303-High Dose
Drug: MT-1303-High

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 13, 2013

First Submitted That Met QC Criteria

November 13, 2013

First Posted (Estimate)

November 19, 2013

Study Record Updates

Last Update Posted (Estimate)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 16, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-1303-E06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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