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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: M518101
* Drug: placebo
* Drug: Dovonex


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 25ug M518101<br> | Drug: M518101<br>* Proper quantity twice a day<br>|
| Placebo Comparator: Vehicle<br> | Drug: placebo<br>* Proper quantity twice a day<br>|
| Active Comparator: Dovonex<br> | Drug: Dovonex<br>* Proper quantity twice a day<br>|
| Experimental: 50ug M518101<br> | Drug: M518101<br>* Proper quantity twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of plaque psoriasis |  | 8 weeks after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator global assessment |  | 8 weeks after dosing |