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

NCT01878461

Run by

Maruho North America Inc.

People needed

542

Starts

2013-06-01

Expected to finish

2015-05-01

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

• Agave Clinical Research — Mesa, Arizona, United States
• T Joseph Raoof — Encino, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Therapeutics Clinical Research — San Diego, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Horizons Clinical Research Center — Denver, Colorado, United States
• The Center for Clinical and Cosmetic Research — Aventura, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Northshore University Health System — Skokie, Illinois, United States
• South Bend Clinic — South Bend, Indiana, United States
• Kansas City Dermatology — Overland Park, Kansas, United States
• Derm Research — Louiville, Kentucky, United States
• Dermatology Specialists Research — Lousville, Kentucky, United States
• Medical Development Center — Baton Rouge, Louisiana, United States
• Grekin Skin Institute — Warren, Michigan, United States
• Washington University Dermatology — St Louis, Missouri, United States
• Karl G Heine Dermatology — Henderson, Nevada, United States
• Las Vegas Skin and Cancer Center — Las Vegas, Nevada, United States
• Center of Central New Jersey — East Windsor, New Jersey, United States
• Skin Search of Rochester — Rochester, New York, United States
• Derm Research Center of New York — Stony Brook, New York, United States
• PMG Research of Charlotte — Charlotte, North Carolina, United States
• Dermatology Consulting Services — High Point, North Carolina, United States
• Medical Development Center — Wilmington, North Carolina, United States
• Radiant Research — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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