Clinical trial NCT01873677: Study to Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis
Official title: A Randomized, Vehicle Controlled, Double Blind, Parallel Group, Multi Center Phase III 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: 2013-06-10
Enrollment: 537
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: Mobile
country: United States
facility: Coastal Clinical Research
state: Alabama
city: Phoenix
country: United States
facility: Omni Dermatology
state: Arizona
city: San Diego
country: United States
facility: Skin Surgery Medical Group
state: California
city: San Diego
country: United States
facility: University Clinical Trials
state: California
city: New Haven
country: United States
facility: The Savin Center
state: Connecticut
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: North Florida Dermatology Associates
state: Florida
city: Miami
country: United States
facility: International Dermatology Research Inc
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: Pinellas Park
country: United States
facility: Belleair Research Center
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Lake Charles
country: United States
facility: Shondra Smith Dermatology & Advanced Aesthetics
state: Louisiana
city: Edina
country: United States
facility: Radiant Research
state: Minnesota
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Cary
country: United States
facility: PMG research of Raleigh
state: North Carolina
city: Wilmington
country: United States
facility: Atlantic Dermatology Associates
state: North Carolina
city: Winston Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma University Health Science Center
state: Oklahoma
city: Fort Washington
country: United States
facility: Philadelphia Institute of Dermatology
state: Pennsylvania
city: Hazelton
country: United States
facility: Derm Dox Center for Dermatology
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners
state: Rhode Island
city: Providence
country: United States
facility: Rhode Island Hospital Dermatology
state: Rhode Island
city: Greer
country: United States
facility: Radiant Research
state: South Carolina
city: Houston
country: United States
facility: The Center for Skin Research
state: Texas
city: Katy
country: United States
facility: Suzanne Bruce and Associates The Center for Skin Research
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Res.
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Seattle
country: United States
facility: Dermatology Associates
state: Washington
Study officials:
References: