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



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2013
End Date:May 2015

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An Open-label, Multi-center, Long-term Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis

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


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
31
sites
Salt Lake City, Utah 84124
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4495 Hale Parkway
Denver, Colorado 80220
303-399-4067
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4085 University Blvd S # 1
Jacksonville, Florida 32216
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
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Atlanta, GA
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Bakersfield, CA
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Boca Raton, Florida 33486
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Cary, North Carolina 27518
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Cincinnati, Ohio 45249
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Fridley, Minnesota 55432
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Henderson, Nevada 89074
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Houston, Texas 77056
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Kingsport, Tennessee 37660
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Knoxville, Tennessee 37922
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Knoxville, Tennessee 37917
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Lake Oswego, OR
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Los Angeles, California 90045
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Madison, Wisconsin 53719
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Mesa, Arizona 85202
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Miramar, Florida 33027
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70 Washington Square S
New York, New York 10012
(212) 998-1212
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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Overland Park, Kansas 66215
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Plano, Texas 75093
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San Antonio, Texas 78229
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San Diego, California 92108
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Santa Monica, California 90404
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Skokie, Illinois 60077
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211 North Eddy St.
South Bend, Indiana 46617
574-234-8161
South Bend Clinic The South Bend Clinic employs a staff of 610 at its five...
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Tampa, FL
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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Wilmington, NC
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