Study to Investigate the Efficacy and the Safety of M518101 in Psoriasis Patients

November 2, 2010 updated by: Maruho Co., Ltd.
This study is to investigate the efficacy and safety of M518101 in male and female plaque psoriasis patients with refractory plaques.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

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

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

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Who are able and willing to give signed informed consent
  • Who are male or females aged between 18 and 65 years with plaque psoriasis confirmed by the Investigator.
  • Who have less than 20% of body surface area (BSA) afflicted with plaques
  • Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.

Exclusion Criteria:

  • Who have a history of allergy to vitamin D3 derivative preparations.
  • Who have a history of relevant drug hypersensitivity.
  • Who have a history of contact dermatitis induced by a topical medicine.
  • Who are pregnant or lactating.
  • Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
  • Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study.
  • Whose serum calcium levels exceed the upper limit of reference range
  • Who have used any investigational medicinal product and/or participated in any clinical study within 24 weeks
  • Who have been treated with systemic therapy within 8 weeks
  • Who have been treated with biologics within 12 weeks
  • Who have been treated with topical therapy during the wash-out and lead-in period.

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

  • Allocation: Randomized
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Severity of plaque psoriasis

Secondary Outcome Measures

Outcome Measure
Investigator and Patient overall assessment

Collaborators and Investigators

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

Sponsor

Maruho Co., Ltd.

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

July 1, 2009

Study Completion

December 1, 2009

Study Registration Dates

First Submitted

April 17, 2009

First Submitted That Met QC Criteria

April 17, 2009

First Posted (Estimate)

April 20, 2009

Study Record Updates

Last Update Posted (Estimate)

November 3, 2010

Last Update Submitted That Met QC Criteria

November 2, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M518101-EU03

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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