Study to Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis
This trial is active, not recruiting.
|Sponsor||Maruho North America Inc.|
|Start date||June 2013|
|End date||September 2015|
|Trial size||522 participants|
|Trial identifier||NCT01873677, M518101-US02|
This study is to evaluate the efficacy and safety of M518101 in subjects with plaque psoriasis.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
hide locations and contact info
|Mobile, AL||Coastal Clinical Research||no longer recruiting|
|Phoenix, AZ||Omni Dermatology||no longer recruiting|
|San Diego, CA||Skin Surgery Medical Group||no longer recruiting|
|San Diego, CA||University Clinical Trials||no longer recruiting|
|New Haven, CT||The Savin Center||no longer recruiting|
|Boynton Beach, FL||Visions Clinical Research||no longer recruiting|
|Jacksonville, FL||North Florida Dermatology Associates||no longer recruiting|
|Miami, FL||International Dermatology Research Inc||no longer recruiting|
|Miramar, FL||FXM Research Miramar||no longer recruiting|
|Ocala, FL||Renstar Medical Research||no longer recruiting|
|Pinellas Park, FL||Belleair Research Center||no longer recruiting|
|Tampa, FL||Olympian Clinical Research||no longer recruiting|
|Indianapolis, IN||Dawes Fretzin Clinical Research Group||no longer recruiting|
|Plainfield, IN||The Indiana Clinical Trials Center||no longer recruiting|
|Lake Charles, LA||Shondra Smith Dermatology & Advanced Aesthetics||no longer recruiting|
|Edina, MN||Radiant Research||no longer recruiting|
|Fridley, MN||Minnesota Clinical Study Center||no longer recruiting|
|Cary, NC||PMG research of Raleigh||no longer recruiting|
|Wilmington, NC||Atlantic Dermatology Associates||no longer recruiting|
|Winston Salem, NC||Wake Forest University||no longer recruiting|
|Oklahoma City, OK||Oklahoma University Health Science Center||no longer recruiting|
|Fort Washington, PA||Philadelphia Institute of Dermatology||no longer recruiting|
|Hazelton, PA||Derm Dox Center for Dermatology||no longer recruiting|
|Johnston, RI||Clinical Partners||no longer recruiting|
|Providence, RI||Rhode Island Hospital Dermatology||no longer recruiting|
|Greer, SC||Radiant Research||no longer recruiting|
|Houston, TX||The Center for Skin Research||no longer recruiting|
|Katy, TX||Suzanne Bruce and Associates The Center for Skin Research||no longer recruiting|
|San Antonio, TX||Dermatology Clinical Res.||no longer recruiting|
|Webster, TX||Center for Clinical Studies||no longer recruiting|
|Seattle, WA||Dermatology Associates||no longer recruiting|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Proper quantity twice a day
Proper quantity twice a day
Investigator Global Assessment
time frame: 8 weeks after dosing
Male or female participants at least 18 years old.
- 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.
|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|
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