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

An Open-label, Multi-center, Long-term Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis

This study is to evaluate the efficacy and safety for long term use of M518101 in subjects with plaque psoriasis.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85202
      • Agave Clinical Research
  • California
    • Bakersfield, California, United States, 93309
      • Bakersfield Dermatology and Skin Cancer Medical Group
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research
    • Santa Monica, California, United States, 90404
      • ATS Clinical Research
  • Colorado
    • Denver, Colorado, United States, 80220
      • Horizons Clinical Research Center
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Dermatology and Aesthetic Center Skin Care
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Miramar, Florida, United States, 33027
      • FXM Research Miramar
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Tampa, Florida, United States, 33612
      • USF Health Morsani Center For Advanced Healthcare
  • Georgia
    • Atlanta, Georgia, United States, 30327
      • Peachtree Dermatology Associates Research Center
  • 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
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • Nevada
    • Henderson, Nevada, United States, 89074
      • J Woodson Dermatology and Associates
  • New York
    • New York, New York, United States, 10016
      • New York University
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • PMG Research of Raleigh
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research
  • Oregon
    • Lake Oswego, Oregon, United States, 97035
      • Bager Allergy, Asthma and Dermatology Research Center
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Pmg Research of Bristol
    • Knoxville, Tennessee, United States, 37922
      • The Skin Wellness Center
    • Knoxville, Tennessee, United States, 37917
      • Dermatology Associates of Knoxville
  • Texas
    • Houston, Texas, United States, 77056
      • Suzanne Bruce & Associates
    • Plano, Texas, United States, 75093
      • Research Across America
    • San Antonio, Texas, United States, 78229
      • Progressive Clinical Research
    • San Antonio, Texas, United States, 78249
      • Stephen Miller
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Dermatology Research Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53719
      • Madison Skin & Research

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 treatment.
• Who have been treated with systemic therapy within 30days of treatment.
• Who have treated with biologics within 5 half-lives of the biologics before the day of treatment
• Who have been treated with topical therapy within 14days before the day of treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: M518101; Proper quantity twice daily	Drug: M518101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time course change of Investigator Global Assessment	4 weeks interval

Collaborators and Investigators

• Sponsor: Maruho North America Inc.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: July 23, 2013
• First Submitted That Met QC Criteria: July 23, 2013
• First Posted (Estimate): July 25, 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-US04