Study to 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:April 2015

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A Randomized, Vehicle Controlled, Double Blind, Parallel Group, Multi Center Phase III 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
31
sites
New Haven, Connecticut 06511
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New Haven, CT
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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Ocala, FL
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Boynton Beach, Florida 33472
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Cary, North Carolina 27518
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Cary, NC
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Edina, Minnesota 55435
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Edina, MN
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Fort Washington, Pennsylvania 19034
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Fort Washington, PA
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Fridley, Minnesota 55432
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Greer, South Carolina
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Greer, SC
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Hazelton, Pennsylvania 18201
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Hazelton, PA
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Houston, Texas 77056
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Houston, TX
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Indianapolis, Indiana 46256
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Indianapolis, IN
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Jacksonville, Florida 32204
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Jacksonville, FL
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Johnston, Rhode Island 02919
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Johnston, RI
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Katy, TX
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Lake Charles, Louisiana 70605
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Lake Charles, LA
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Miami, FL
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Miramar, Florida 33027
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Miramar, FL
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Mobile, Alabama 36608
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Mobile, AL
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Phoenix, Arizona 85108
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Pinellas Park, Florida 33781
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Plainfield, Indiana 46168
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Plainfield, IN
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Providence, Rhode Island 02903
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Providence, RI
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San Antonio, Texas 78229
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San Diego, California 92117
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San Diego, California 92123
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Seattle, Washington 98101
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Tampa, Florida 33609
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Webster, Texas 77598
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Wilmington, North Carolina 28401
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Winston Salem, North Carolina 27157
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Winston Salem, NC
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