Study to Investigate the Efficacy and the Safety of M518101 in Plaque Psoriasis Patients



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2011

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This study is to evaluate the efficacy and safety of M518101 and the dose relationship among
two doses of M518101 and placebo in male and female plaque psoriasis patients.

This study is to evaluate the efficacy and safety of M518101 and the dose response
relationship among two doses of M518101 and placebo in male and female plaque psoriasis
patients and to confirm the persistence of the effect of M518101.

Inclusion Criteria:

1. Who are able and willing to give signed informed consent

2. Who are male or females aged 18 years or older with plaque psoriasis confirmed by the
Investigator.

3. Who have less than 20% of body surface area (BSA) afflicted with plaques

4. Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the
study.

Exclusion Criteria:

1. Who have a history of allergy to vitamin D3 derivative preparations.

2. Who have a history of relevant drug hypersensitivity.

3. Who have a history of contact dermatitis induced by a topical medicine.

4. Who are pregnant or lactating.

5. Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal
or hepatic disease.

6. Who are not deemed eligible as determined by medical history, physical examination or
clinical laboratory safety tests.

7. 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.

8. Whose serum calcium levels exceed the upper limit of reference range

9. Who have used any investigational medicinal product and/or participated in any
clinical study within 60 days before the day of signing the ICF.

10. Who have been treated with systemic therapy within 2 weeks before the day of signing
the ICF and during the wash-out period.

11. Who have been treated with biologics within 5 half-lives of the biologics before the
day of randomization.

12. Who have been treated with topical therapy during the wash-out period.
We found this trial at
32
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Columbus, Ohio 43212
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725 West Granada Blvd
Ormond Beach, Florida 32174
386-898-0547
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Alpharetta, Georgia 30022
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Arlington, Texas 76011
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Baton Rouge, Louisiana 70808
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Birmingham, Alabama 35233
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Boynton Beach, Florida 33472
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Fort Gratiot, Michigan 48059
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Fresno, California 93710
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Greenville, South Carolina 29607
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High Point, North Carolina 27262
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Indianapolis, Indiana 46256
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Jacsonville, Florida 32216
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Lake Oswego, OR
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Louisville, Kentucky 40217
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Mobile, Alabama 36608
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Norfolk, Virginia 23507
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Oklahoma, Oklahoma 73104
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Opelousas, Louisiana 70570
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Rochester, New York 14623
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San Antonio, Texas 78229
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San Diego, California 92123
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Santa Monica, California 90404
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Seattle, Washington 98101
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Skokie, Illinois 60076
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South Bend, Indiana 46617
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St. Louis, Missouri 63117
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Stony Brook, New York 11790
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Wilmington, North Carolina 28403
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