Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis
- Registration Number
- NCT01878461
- Lead Sponsor
- Maruho North America Inc.
- Brief Summary
This study is to evaluate the efficacy and safety of M518101 in subjects with plaque psoriasis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 542
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description M518101 M518101 Proper quantity twice a day Vehicle Vehicle Proper quantity twice a day
- Primary Outcome Measures
Name Time Method Investigator Global Assessment 8 weeks after dosing
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
T Joseph Raoof
🇺🇸Encino, California, United States
Agave Clinical Research
🇺🇸Mesa, Arizona, United States
Grekin Skin Institute
🇺🇸Warren, Michigan, United States
Washington University Dermatology
🇺🇸St. Louis, Missouri, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
Dermatology Specialists Research
🇺🇸Lousville, Kentucky, United States
Center of Central New Jersey
🇺🇸East Windsor, New Jersey, United States
Skin Search of Rochester
🇺🇸Rochester, New York, United States
The Center for Clinical and Cosmetic Research
🇺🇸Aventura, Florida, United States
Northshore University Health System
🇺🇸Skokie, Illinois, United States
Menter Dermatology Research Institute
🇺🇸Dallas, Texas, United States
Palmetto Clinical Trial Servises
🇺🇸Fountain Inn, South Carolina, United States
Karl G Heine Dermatology
🇺🇸Henderson, Nevada, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Derm Research Center of New York
🇺🇸Stony Brook, New York, United States
Derm Research
🇺🇸Louiville, Kentucky, United States
Medical Development Center
🇺🇸Wilmington, North Carolina, United States
Therapeutics Clinical Research
🇺🇸San Diego, California, United States
Las Vegas Skin and Cancer Center
🇺🇸Las Vegas, Nevada, United States
Clinical Trials of Texas
🇺🇸San Antonio, Texas, United States
Kansas City Dermatology
🇺🇸Overland Park, Kansas, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
Coastal Clinical Research Center
🇺🇸Mt Pleasant, South Carolina, United States
Dermatology Consulting Services
🇺🇸High Point, North Carolina, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
PMG Research of Charlotte
🇺🇸Charlotte, North Carolina, United States
Horizons Clinical Research Center
🇺🇸Denver, Colorado, United States
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States
Austin Dermatology Associates
🇺🇸Austin, Texas, United States
DermResearch
🇺🇸Austin, Texas, United States
Dermatology Research Center
🇺🇸Salt Lake City, Utah, United States
Radiant Research
🇺🇸Cincinnati, Ohio, United States