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

A Randomized, Vehicle Controlled, Double Blind, Parallel Group, Multi Center Phase III 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): 537
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Omni Dermatology
  • California
    • San Diego, California, United States, 92123
      • University Clinical Trials
    • San Diego, California, United States, 92117
      • Skin Surgery Medical Group
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • The Savin Center
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Visions Clinical Research
    • Jacksonville, Florida, United States, 32204
      • North Florida Dermatology Associates
    • Miami, Florida, United States, 33144
      • International Dermatology Research Inc
    • Miramar, Florida, United States, 33027
      • FXM Research Miramar
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Pinellas Park, Florida, United States, 33781
      • Belleair Research Center
    • Tampa, Florida, United States, 33609
      • Olympian Clinical Research
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Clinical Research Group
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Shondra Smith Dermatology & Advanced Aesthetics
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Radiant Research
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • PMG Research of Raleigh
    • Wilmington, North Carolina, United States, 28401
      • Atlantic Dermatology Associates
    • Winston Salem, North Carolina, United States, 27104
      • Wake Forest University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University Health Science Center
  • Pennsylvania
    • Fort Washington, Pennsylvania, United States, 19034
      • Philadelphia Institute of Dermatology
    • Hazelton, Pennsylvania, United States, 18201
      • Derm Dox Center for Dermatology
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital Dermatology
  • South Carolina
    • Greer, South Carolina, United States, 29650
      • Radiant Research
  • Texas
    • Houston, Texas, United States, 77056
      • The Center for Skin Research
    • Katy, Texas, United States, 77494
      • Suzanne Bruce and Associates The Center for Skin Research
    • San Antonio, Texas, United States, 78229
      • Dermatology Clinical Res.
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies
  • Washington
    • Seattle, Washington, United States, 98101
      • Dermatology Associates

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): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: June 6, 2013
• First Submitted That Met QC Criteria: June 6, 2013
• First Posted (Estimate): June 10, 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-US02