Psoriasis Clinical Trial
Study to Investigate the Efficacy and the Safety of M518101 in Plaque Psoriasis Patients
Summary
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.
Full Description
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.
Eligibility Criteria
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 less than 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.
Who have a history of relevant drug hypersensitivity.
Who have a history of contact dermatitis induced by a topical medicine.
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 before the day of signing the ICF.
Who have been treated with systemic therapy within 2 weeks before the day of signing the ICF and during the wash-out period.
Who have been treated with biologics within 5 half-lives of the biologics before the day of randomization.
Who have been treated with topical therapy during the wash-out period.
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There are 32 Locations for this study
Birmingham Alabama, 35233, United States
Mobile Alabama, 36608, United States
Fresno California, 93710, United States
San Diego California, 92123, United States
Santa Monica, California, 90404, United States
Boynton Beach Florida, 33472, United States
Jacsonville Florida, 32216, United States
Ormond Beach Florida, 32174, United States
Alpharetta Georgia, 30022, United States
Skokie Illinois, 60077, United States
Indianapolis Indiana, 46256, United States
South Bend Indiana, 46617, United States
Louisville Kentucky, 40217, United States
Baton Rouge Louisiana, 70808, United States
Opelousas Louisiana, 70570, United States
Fort Gratiot Michigan, 48059, United States
Saint Louis Missouri, 63141, United States
St. Louis Missouri, 63117, United States
Lebanon New Hampshire, 03756, United States
Rochester New York, 14623, United States
Stony Brook New York, 11790, United States
High Point North Carolina, 27262, United States
Wilmington North Carolina, 28403, United States
Columbus Ohio, 43212, United States
Oklahoma Oklahoma, 73104, United States
Lake Oswego Oregon, 97035, United States
Greenville South Carolina, 29607, United States
Arlington Texas, 76011, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Norfolk Virginia, 23507, United States
Seattle Washington, 98101, United States
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