Clinical trial NCT01878461: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Maruho North America Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-17
Enrollment: 542
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Investigator Global Assessment
timeFrame: 8 weeks after dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Agave Clinical Research
state: Arizona
city: Encino
country: United States
facility: T Joseph Raoof
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center
state: Colorado
city: Aventura
country: United States
facility: The Center for Clinical and Cosmetic Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Skokie
country: United States
facility: Northshore University Health System
state: Illinois
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Dermatology
state: Kansas
city: Louiville
country: United States
facility: Derm Research
state: Kentucky
city: Lousville
country: United States
facility: Dermatology Specialists Research
state: Kentucky
city: Baton Rouge
country: United States
facility: Medical Development Center
state: Louisiana
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: St. Louis
country: United States
facility: Washington University Dermatology
state: Missouri
city: Henderson
country: United States
facility: Karl G Heine Dermatology
state: Nevada
city: Las Vegas
country: United States
facility: Las Vegas Skin and Cancer Center
state: Nevada
city: East Windsor
country: United States
facility: Center of Central New Jersey
state: New Jersey
city: Rochester
country: United States
facility: Skin Search of Rochester
state: New York
city: Stony Brook
country: United States
facility: Derm Research Center of New York
state: New York
city: Charlotte
country: United States
facility: PMG Research of Charlotte
state: North Carolina
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Wilmington
country: United States
facility: Medical Development Center
state: North Carolina
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Fountain Inn
country: United States
facility: Palmetto Clinical Trial Servises
state: South Carolina
city: Mt Pleasant
country: United States
facility: Coastal Clinical Research Center
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Austin
country: United States
facility: Austin Dermatology Associates
state: Texas
city: Austin
country: United States
facility: DermResearch
state: Texas
city: Dallas
country: United States
facility: Menter Dermatology Research Institute
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center
state: Utah
Study officials:
References: