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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878461
• Other study ID #: M518101-US03
• Status: Completed
• Phase: Phase 3
• First received: June 6, 2013
• Last updated: August 14, 2015
• Start date: June 2013
• Est. completion date: May 2015

Study information

• Verified date: August 2015
• Source: Maruho North America Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 542
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Vehicle

• M518101

Locations

Country	Name	City	State
United States	Austin Dermatology Associates	Austin	Texas
United States	DermResearch	Austin	Texas
United States	The Center for Clinical and Cosmetic Research	Aventura	Florida
United States	Medical Development Center	Baton Rouge	Louisiana
United States	PMG Research of Charlotte	Charlotte	North Carolina
United States	Radiant Research	Cincinnati	Ohio
United States	Menter Dermatology Research Institute	Dallas	Texas
United States	Horizons Clinical Research Center	Denver	Colorado
United States	Center of Central New Jersey	East Windsor	New Jersey
United States	T Joseph Raoof	Encino	California
United States	Palmetto Clinical Trial Servises	Fountain Inn	South Carolina
United States	Karl G Heine Dermatology	Henderson	Nevada
United States	Dermatology Consulting Services	High Point	North Carolina
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Las Vegas Skin and Cancer Center	Las Vegas	Nevada
United States	Derm Research	Louiville	Kentucky
United States	Dermatology Specialists Research	Lousville	Kentucky
United States	Agave Clinical Research	Mesa	Arizona
United States	Coastal Clinical Research Center	Mt Pleasant	South Carolina
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Central Sooner Research	Norman	Oklahoma
United States	Kansas City Dermatology	Overland Park	Kansas
United States	Skin Search of Rochester	Rochester	New York
United States	Dermatology Research Center	Salt Lake City	Utah
United States	Clinical Trials of Texas	San Antonio	Texas
United States	Medical Center for Clinical Research	San Diego	California
United States	Therapeutics Clinical Research	San Diego	California
United States	Clinical Science Institute	Santa Monica	California
United States	Northshore University Health System	Skokie	Illinois
United States	South Bend Clinic	South Bend	Indiana
United States	Washington University Dermatology	St. Louis	Missouri
United States	Derm Research Center of New York	Stony Brook	New York
United States	Grekin Skin Institute	Warren	Michigan
United States	Medical Development Center	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Maruho North America Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator Global Assessment		8 weeks after dosing	No