Clinical trial NCT01908595: Long Term Study to Evaluate Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis
Official title: An Open-label, Multi-center, Long-term 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: 2013-07-25
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the efficacy and safety for long term use 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 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.

Primary outcomes:
measure: Time course change of Investigator Global Assessment
timeFrame: 4 weeks interval
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Agave Clinical Research
state: Arizona
city: Bakersfield
country: United States
facility: Bakersfield Dermatology and Skin Cancer Medical Group
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Santa Monica
country: United States
facility: ATS Clinical Research
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center
state: Colorado
city: Boca Raton
country: United States
facility: Dermatology and Aesthetic Center Skin Care
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Miramar
country: United States
facility: FXM Research Miramar
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Tampa
country: United States
facility: USF Health Morsani Center for Advanced Healthcare
state: Florida
city: Atlanta
country: United States
facility: Peachtree Dermatology Associates Research Center
state: Georgia
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: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Henderson
country: United States
facility: J Woodson Dermatology and Associates
state: Nevada
city: New York
country: United States
facility: New York University
state: New York
city: Cary
country: United States
facility: PMG research of raleigh
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
city: Lake Oswego
country: United States
facility: Bager Allergy, Asthma and Dermatology Research Center
state: Oregon
city: Kingsport
country: United States
facility: PMG Research of Bristol
state: Tennessee
city: Knoxville
country: United States
facility: Dermatology Associates of Knoxville
state: Tennessee
city: Knoxville
country: United States
facility: The skin wellness center
state: Tennessee
city: Houston
country: United States
facility: Suzanne Bruce & Associates
state: Texas
city: Plano
country: United States
facility: Research Across America
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Stephen Miller
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center
state: Utah
city: Madison
country: United States
facility: Madison Skin & Research
state: Wisconsin
Study officials:
References: