Study to Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis
- Registration Number
- NCT01873677
- 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
- 537
- 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 (30)
Coastal Clinical Research
🇺🇸Mobile, Alabama, United States
The Center for Skin Research
🇺🇸Houston, Texas, United States
Dawes Fretzin Clinical Research Group
🇺🇸Indianapolis, Indiana, United States
Skin Surgery Medical Group
🇺🇸San Diego, California, United States
Belleair Research Center
🇺🇸Pinellas Park, Florida, United States
Olympian Clinical Research
🇺🇸Tampa, Florida, United States
Derm Dox Center for Dermatology
🇺🇸Hazelton, Pennsylvania, United States
International Dermatology Research Inc
🇺🇸Miami, Florida, United States
FXM Research Miramar
🇺🇸Miramar, Florida, United States
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
Dermatology Associates
🇺🇸Seattle, Washington, United States
Suzanne Bruce and Associates The Center for Skin Research
🇺🇸Katy, Texas, United States
Omni Dermatology
🇺🇸Phoenix, Arizona, United States
University Clinical Trials
🇺🇸San Diego, California, United States
Visions Clinical Research
🇺🇸Boynton Beach, Florida, United States
The Savin Center
🇺🇸New Haven, Connecticut, United States
North Florida Dermatology Associates
🇺🇸Jacksonville, Florida, United States
Wake Forest University
🇺🇸Winston Salem, North Carolina, United States
Clinical Partners
🇺🇸Johnston, Rhode Island, United States
Dermatology Clinical Res.
🇺🇸San Antonio, Texas, United States
Rhode Island Hospital Dermatology
🇺🇸Providence, Rhode Island, United States
Center for Clinical Studies
🇺🇸Webster, Texas, United States
The Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
PMG research of Raleigh
🇺🇸Cary, North Carolina, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Shondra Smith Dermatology & Advanced Aesthetics
🇺🇸Lake Charles, Louisiana, United States
Atlantic Dermatology Associates
🇺🇸Wilmington, North Carolina, United States
Oklahoma University Health Science Center
🇺🇸Oklahoma City, Oklahoma, United States
Philadelphia Institute of Dermatology
🇺🇸Fort Washington, Pennsylvania, United States
Radiant Research
🇺🇸Greer, South Carolina, United States