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

October 12, 2015 updated by: Maruho Co., Ltd.
This study is to evaluate the efficacy and safety of M518101 and the dose relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is to evaluate the efficacy and safety of M518101 and the dose response relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients and to confirm the persistence of the effect of M518101.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
294

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama (UAB) Dermatology
      • Mobile, Alabama, United States, 36608
        • Coastal Carolina Research
    • California
      • Fresno, California, United States, 93710
        • Sierra Medical Research
      • San Diego, California, United States, 92123
        • Therapeutics Clinical Research
      • Santa Monica,, California, United States, 90404
        • Clinical Science Institute
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Visions Clinical Research
      • Jacsonville, Florida, United States, 32216
        • Ameriderm Research
      • Ormond Beach, Florida, United States, 32174
        • Ameriderm Research
    • Georgia
      • Alpharetta, Georgia, United States, 30022
        • Atlanta Dermatology, Vein & Research Ctr
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Northshore University Healthsystem
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Dawes Fretzin Clinical Research Group, LLC
      • South Bend, Indiana, United States, 46617
        • The Southbend Clinic, LLC
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Derm Research
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Medical Development Centers, LLC
      • Opelousas, Louisiana, United States, 70570
        • Medical Development Centers, LLC
    • Michigan
      • Fort Gratiot, Michigan, United States, 48059
        • Hamzavi Dermatology
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Washington University, Dermatology Clinical Trials Unit
      • St. Louis, Missouri, United States, 63117
        • Central Dermatology
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center, Section of Dermatology
    • New York
      • Rochester, New York, United States, 14623
        • Skin Search Of Rochester, Inc.
      • Stony Brook, New York, United States, 11790
        • DermResearchCenter of New York, Inc
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Dermatology Consulting Services
      • Wilmington, North Carolina, United States, 28403
        • Wilmington Dermatology Center
    • Ohio
      • Columbus, Ohio, United States, 43212
        • Radiant Research
    • Oklahoma
      • Oklahoma, Oklahoma, United States, 73104
        • OUHSC-Dermatology
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Baker Allergy, Asthma and Dermatology Research Center, LLC
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Palmetto Clinical Trial Services, LLC
    • Texas
      • Arlington, Texas, United States, 76011
        • Arlington Research Center, Inc
      • Houston, Texas, United States, 77030
        • Center for Clinical Studies, Texas Medical Center
      • San Antonio, Texas, United States, 78229
        • Dermatology Clinical Research Center
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Virginia Clinical Research Inc.
    • Washington
      • Seattle, Washington, United States, 98101
        • Dermatology Associates

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Who have a history of allergy to vitamin D3 derivative preparations.
  2. Who have a history of relevant drug hypersensitivity.
  3. Who have a history of contact dermatitis induced by a topical medicine.
  4. Who are pregnant or lactating.
  5. Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
  6. Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
  7. 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.
  8. Whose serum calcium levels exceed the upper limit of reference range
  9. Who have used any investigational medicinal product and/or participated in any clinical study within 60 days before the day of signing the ICF.
  10. Who have been treated with systemic therapy within 2 weeks before the day of signing the ICF and during the wash-out period.
  11. Who have been treated with biologics within 5 half-lives of the biologics before the day of randomization.
  12. Who have been treated with topical therapy during the wash-out 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

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Vehicle
Drug: placebo
Proper quantity twice a day
Experimental: 25ug M518101
Drug: M518101
Proper quantity twice a day
Active Comparator: Dovonex
Drug: Dovonex
Proper quantity twice a day
Experimental: 50ug M518101
Drug: M518101
Proper quantity twice a day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
severity of plaque psoriasis
Time Frame: 8 weeks after dosing
8 weeks after dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Investigator global assessment
Time Frame: 8 weeks after dosing
8 weeks after dosing

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M518101-US01

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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