Evaluate the Efficacy and Safety 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:June 2013
End Date:May 2015

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A Randomized, Vehicle Controlled, Double Blind, Parallel Group, Multi Center PhaseIII Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis

This study is to evaluate the efficacy and safety 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 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.
We found this trial at
34
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Louiville, Kentucky 40217
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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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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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Austin, Texas 78705
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Austin, Texas 78759
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Aventura, FL
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Baton Rouge, Louisiana 70808
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Charlotte, North Carolina 28209
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Cincinnati, Ohio 45249
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Dallas, TX
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East Windsor, New Jersey 08520
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Encino, California 91436
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Fountain Inn, South Carolina 29644
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Henderson, Nevada 89052
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High Point, North Carolina 27262
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Las Vegas, Nevada 89106
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Lousville, Kentucky 40202
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Mesa, Arizona 85202
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Mt Pleasant, South Carolina 29464
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Nashville, Tennessee 37215
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Norman, Oklahoma 73069
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Overland Park, Kansas 66215
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Rochester, New York 14623
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Salt Lake City, Utah 84124
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San Diego, California 92108
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San Diego, California 92123
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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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St. Louis, Missouri 63141
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Stony Brook, New York 11790
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Warren, Michigan 48093
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Wilmington, North Carolina 28403
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