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

Completed · Phase 3

Conditions studied: Psoriasis

In brief

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

Key facts

Study ID

NCT01908595

Run by

Maruho North America Inc.

People needed

480

Starts

2013-08-01

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 treatment.
• Who have been treated with systemic therapy within 30days of treatment.
• Who have treated with biologics within 5 half-lives of the biologics before the day of treatment
• Who have been treated with topical therapy within 14days before the day of treatment.

Where it is running

• Agave Clinical Research — Mesa, Arizona, United States
• Bakersfield Dermatology and Skin Cancer Medical Group — Bakersfield, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• ATS Clinical Research — Santa Monica, California, United States
• Horizons Clinical Research Center — Denver, Colorado, United States
• Dermatology and Aesthetic Center Skin Care — Boca Raton, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• FXM Research Miramar — Miramar, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• USF Health Morsani Center for Advanced Healthcare — Tampa, Florida, United States
• Peachtree Dermatology Associates Research Center — Atlanta, Georgia, 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
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• J Woodson Dermatology and Associates — Henderson, Nevada, United States
• New York University — New York, New York, United States
• PMG research of raleigh — Cary, North Carolina, United States
• PMG Research of Wilmington — Wilmington, North Carolina, United States
• Radiant Research — Cincinnati, Ohio, United States
• Bager Allergy, Asthma and Dermatology Research Center — Lake Oswego, Oregon, United States
• PMG Research of Bristol — Kingsport, Tennessee, United States
• Dermatology Associates of Knoxville — Knoxville, Tennessee, United States
• The skin wellness center — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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