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
Edina, Minnesota 55435
544
mi
from
Edina, MN
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
1078
mi
from
Ocala, FL
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Boynton Beach, Florida 33472
1292
mi
from
Boynton Beach, FL
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Cary, North Carolina 27518
1061
mi
from
Cary, NC
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Fort Washington, Pennsylvania 19034
1222
mi
from
Fort Washington, PA
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Fridley, Minnesota 55432
559
mi
from
Fridley, MN
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Greer, South Carolina
888
mi
from
Greer, SC
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Hazelton, Pennsylvania 18201
1186
mi
from
Hazelton, PA
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Houston, Texas 77056
569
mi
from
Houston, TX
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Indianapolis, Indiana 46256
652
mi
from
Indianapolis, IN
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Jacksonville, Florida 32204
1054
mi
from
Jacksonville, FL
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Johnston, Rhode Island 02919
1419
mi
from
Johnston, RI
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562
mi
from
Katy, TX
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Lake Charles, Louisiana 70605
586
mi
from
Lake Charles, LA
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1316
mi
from
Miami, FL
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Miramar, Florida 33027
1304
mi
from
Miramar, FL
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Mobile, Alabama 36608
734
mi
from
Mobile, AL
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New Haven, Connecticut 06511
1344
mi
from
New Haven, CT
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Oklahoma City, Oklahoma 73104
158
mi
from
Oklahoma City, OK
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Phoenix, Arizona 85108
846
mi
from
Phoenix, AZ
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Pinellas Park, Florida 33781
1110
mi
from
Pinellas Park, FL
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Plainfield, Indiana 46168
629
mi
from
Plainfield, IN
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Providence, Rhode Island 02903
1424
mi
from
Providence, RI
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San Antonio, Texas 78229
571
mi
from
San Antonio, TX
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San Diego, California 92117
1142
mi
from
San Diego, CA
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San Diego, California 92123
1143
mi
from
San Diego, CA
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Seattle, Washington 98101
1410
mi
from
Seattle, WA
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Tampa, Florida 33609
1115
mi
from
Tampa, FL
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Webster, Texas 77598
588
mi
from
Webster, TX
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Wilmington, North Carolina 28401
1134
mi
from
Wilmington, NC
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Winston Salem, North Carolina 27157
974
mi
from
Winston Salem, NC
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