Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis

A Randomized, Vehicle Controlled, Double Blind, Parallel Group, Multi Center PhaseIII Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis

This study is to evaluate the efficacy and safety of M518101 in subjects with plaque psoriasis

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Vehicle; Drug: M518101

• Study Type: Interventional
• Enrollment (Actual): 542
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85202
      • Agave Clinical Research
  • California
    • Encino, California, United States, 91436
      • T Joseph Raoof
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
  • Colorado
    • Denver, Colorado, United States, 80220
      • Horizons Clinical Research Center
  • Florida
    • Aventura, Florida, United States, 33180
      • The Center for Clinical and Cosmetic Research
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
  • Illinois
    • Skokie, Illinois, United States, 60077
      • NorthShore University Health System
  • Indiana
    • South Bend, Indiana, United States, 46617
      • South Bend Clinic
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Kansas City Dermatology
  • Kentucky
    • Louiville, Kentucky, United States, 40217
      • Derm Research
    • Lousville, Kentucky, United States, 40202
      • Dermatology Specialists Research
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Medical Development Center
  • Michigan
    • Warren, Michigan, United States, 48088
      • Grekin Skin Institute
  • Missouri
    • St. Louis, Missouri, United States, 63141
      • Washington University Dermatology
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Karl G Heine Dermatology
    • Las Vegas, Nevada, United States, 89106
      • Las Vegas Skin and Cancer Center
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Center of Central New Jersey
  • New York
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester
    • Stony Brook, New York, United States, 11790
      • Derm Research Center of New York
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • PMG Research of Charlotte
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services
    • Wilmington, North Carolina, United States, 28403
      • Medical Development Center
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Central Sooner Research
  • South Carolina
    • Fountain Inn, South Carolina, United States, 29644
      • Palmetto Clinical Trial Servises
    • Mt Pleasant, South Carolina, United States, 29464
      • Coastal Clinical Research Center
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Dermatology Associates
    • Austin, Texas, United States, 78759
      • DermResearch
    • Dallas, Texas, United States, 75246
      • Menter Dermatology Research Institute
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Dermatology Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Who are able and willing to give signed informed consent
• Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator.
• Who have up to 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 or a history of relevant drug hypersensitivity.
• Who are pregnant or lactating.
• Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
• Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
• 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 60 days of randomization.
• Who have been treated with systemic therapy within 30days of randomization.
• Who have treated with biologics within 5 half-lives of the biologics before the day of randomization
• Who have been treated with topical therapy within 14days before the day of randomization.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle; Proper quantity twice a day	Drug: Vehicle
Experimental: M518101; Proper quantity twice a day	Drug: M518101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Investigator Global Assessment	8 weeks after dosing

Collaborators and Investigators

• Sponsor: Maruho North America Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: June 6, 2013
• First Submitted That Met QC Criteria: June 12, 2013
• First Posted (Estimate): June 17, 2013

Study Record Updates

• Last Update Posted (Estimate): September 2, 2015
• Last Update Submitted That Met QC Criteria: August 14, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: M518101-US03