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

Use our guide to learn which trials are right for you!

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
sites
Mobile, Alabama 36608
?
mi
from
Mobile, AL
Click here to add this to my saved trials
725 West Granada Blvd
Ormond Beach, Florida 32174
386-898-0547
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
Alpharetta, Georgia 30022
?
mi
from
Alpharetta, GA
Click here to add this to my saved trials
Arlington, Texas 76011
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Baton Rouge, Louisiana 70808
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Birmingham, Alabama 35233
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boynton Beach, Florida 33472
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
Columbus, Ohio 43212
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Fort Gratiot, Michigan 48059
?
mi
from
Fort Gratiot, MI
Click here to add this to my saved trials
Fresno, California 93710
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Greenville, South Carolina 29607
?
mi
from
Greenville, SC
Click here to add this to my saved trials
High Point, North Carolina 27262
?
mi
from
High Point, NC
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46256
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jacsonville, Florida 32216
?
mi
from
Jacsonville, FL
Click here to add this to my saved trials
?
mi
from
Lake Oswego, OR
Click here to add this to my saved trials
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
Louisville, Kentucky 40217
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Norfolk, Virginia 23507
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Oklahoma, Oklahoma 73104
?
mi
from
Oklahoma, OK
Click here to add this to my saved trials
Opelousas, Louisiana 70570
?
mi
from
Opelousas, LA
Click here to add this to my saved trials
Rochester, New York 14623
?
mi
from
Rochester, NY
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Seattle, Washington 98101
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Skokie, Illinois 60076
?
mi
from
Skokie, IL
Click here to add this to my saved trials
South Bend, Indiana 46617
?
mi
from
South Bend, IN
Click here to add this to my saved trials
St. Louis, Missouri 63117
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
Stony Brook, New York 11790
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
Wilmington, North Carolina 28403
?
mi
from
Wilmington, NC
Click here to add this to my saved trials