Study to Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis

Completed · Phase 3

Conditions studied: Psoriasis

In brief

This study is to evaluate the efficacy and safety of M518101 in subjects with plaque psoriasis.

Key facts

Study ID

NCT01873677

Run by

Maruho North America Inc.

People needed

537

Starts

2013-06-01

Expected to finish

2015-04-01

Last updated by the study team

2015-09-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Coastal Clinical Research — Mobile, Alabama, United States
• Omni Dermatology — Phoenix, Arizona, United States
• Skin Surgery Medical Group — San Diego, California, United States
• University Clinical Trials — San Diego, California, United States
• The Savin Center — New Haven, Connecticut, United States
• Visions Clinical Research — Boynton Beach, Florida, United States
• North Florida Dermatology Associates — Jacksonville, Florida, United States
• International Dermatology Research Inc — Miami, Florida, United States
• FXM Research Miramar — Miramar, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Belleair Research Center — Pinellas Park, Florida, United States
• Olympian Clinical Research — Tampa, Florida, United States
• Dawes Fretzin Clinical Research Group — Indianapolis, Indiana, United States
• The Indiana Clinical Trials Center — Plainfield, Indiana, United States
• Shondra Smith Dermatology & Advanced Aesthetics — Lake Charles, Louisiana, United States
• Radiant Research — Edina, Minnesota, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• PMG research of Raleigh — Cary, North Carolina, United States
• Atlantic Dermatology Associates — Wilmington, North Carolina, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• Oklahoma University Health Science Center — Oklahoma City, Oklahoma, United States
• Philadelphia Institute of Dermatology — Fort Washington, Pennsylvania, United States
• Derm Dox Center for Dermatology — Hazleton, Pennsylvania, United States
• Clinical Partners — Johnston, Rhode Island, United States
• Rhode Island Hospital Dermatology — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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