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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vehicle
M518101
Sponsored by
Maruho North America Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Agave Clinical Research
  • T Joseph Raoof
  • Medical Center for Clinical Research
  • Therapeutics Clinical Research
  • Clinical Science Institute
  • Horizons Clinical Research Center
  • The Center for Clinical and Cosmetic Research
  • Jacksonville Center for Clinical Research
  • Northshore University Health System
  • South Bend Clinic
  • Kansas City Dermatology
  • Derm Research
  • Dermatology Specialists Research
  • Medical Development Center
  • Grekin Skin Institute
  • Washington University Dermatology
  • Karl G Heine Dermatology
  • Las Vegas Skin and Cancer Center
  • Center of Central New Jersey
  • Skin Search of Rochester
  • Derm Research Center of New York
  • PMG Research of Charlotte
  • Dermatology Consulting Services
  • Medical Development Center
  • Radiant Research
  • Central Sooner Research
  • Palmetto Clinical Trial Servises
  • Coastal Clinical Research Center
  • Tennessee Clinical Research Center
  • Austin Dermatology Associates
  • DermResearch
  • Menter Dermatology Research Institute
  • Clinical Trials of Texas
  • Dermatology Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Vehicle

M518101

Arm Description

Proper quantity twice a day

Proper quantity twice a day

Outcomes

Primary Outcome Measures

Investigator Global Assessment

Secondary Outcome Measures

Full Information

First Posted
June 6, 2013
Last Updated
August 14, 2015
Sponsor
Maruho North America Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01878461
Brief Title
Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maruho North America Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
542 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Proper quantity twice a day
Arm Title
M518101
Arm Type
Experimental
Arm Description
Proper quantity twice a day
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Type
Drug
Intervention Name(s)
M518101
Primary Outcome Measure Information:
Title
Investigator Global Assessment
Time Frame
8 weeks after dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Agave Clinical Research
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
T Joseph Raoof
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Horizons Clinical Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
The Center for Clinical and Cosmetic Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Northshore University Health System
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Kansas City Dermatology
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Derm Research
City
Louiville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Dermatology Specialists Research
City
Lousville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Medical Development Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Grekin Skin Institute
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Washington University Dermatology
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Karl G Heine Dermatology
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Las Vegas Skin and Cancer Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Center of Central New Jersey
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Skin Search of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Derm Research Center of New York
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
PMG Research of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Dermatology Consulting Services
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Medical Development Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Radiant Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Palmetto Clinical Trial Servises
City
Fountain Inn
State/Province
South Carolina
ZIP/Postal Code
29644
Country
United States
Facility Name
Coastal Clinical Research Center
City
Mt Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Austin Dermatology Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
DermResearch
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Menter Dermatology Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Clinical Trials of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Dermatology Research Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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