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.

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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.

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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.

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

294

Study ID:

NCT01301157

Recruitment Status:

Completed

Sponsor:

Maruho Co., Ltd.

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There are 32 Locations for this study

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University of Alabama (UAB) Dermatology
Birmingham Alabama, 35233, United States
Coastal Carolina Research
Mobile Alabama, 36608, United States
Sierra Medical Research
Fresno California, 93710, United States
Therapeutics Clinical Research
San Diego California, 92123, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Visions Clinical Research
Boynton Beach Florida, 33472, United States
Ameriderm Research
Jacsonville Florida, 32216, United States
Ameriderm Research
Ormond Beach Florida, 32174, United States
Atlanta Dermatology, Vein & Research Ctr
Alpharetta Georgia, 30022, United States
NorthShore University HealthSystem
Skokie Illinois, 60077, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis Indiana, 46256, United States
The Southbend Clinic, LLC
South Bend Indiana, 46617, United States
Derm Research
Louisville Kentucky, 40217, United States
Medical Development Centers, LLC
Baton Rouge Louisiana, 70808, United States
Medical Development Centers, LLC
Opelousas Louisiana, 70570, United States
Hamzavi Dermatology
Fort Gratiot Michigan, 48059, United States
Washington University, Dermatology Clinical Trials Unit
Saint Louis Missouri, 63141, United States
Central Dermatology
St. Louis Missouri, 63117, United States
Dartmouth-Hitchcock Medical Center, Section of Dermatology
Lebanon New Hampshire, 03756, United States
Skin Search of Rochester, Inc.
Rochester New York, 14623, United States
DermResearchCenter of New York, Inc
Stony Brook New York, 11790, United States
Dermatology Consulting Services
High Point North Carolina, 27262, United States
Wilmington Dermatology Center
Wilmington North Carolina, 28403, United States
Radiant Research
Columbus Ohio, 43212, United States
OUHSC-Dermatology
Oklahoma Oklahoma, 73104, United States
Baker Allergy, Asthma and Dermatology Research Center, LLC
Lake Oswego Oregon, 97035, United States
Palmetto Clinical Trial Services, LLC
Greenville South Carolina, 29607, United States
Arlington Research Center, Inc
Arlington Texas, 76011, United States
Center for Clinical Studies, Texas Medical Center
Houston Texas, 77030, United States
Dermatology Clinical Research Center
San Antonio Texas, 78229, United States
Virginia Clinical Research Inc.
Norfolk Virginia, 23507, United States
Dermatology Associates
Seattle Washington, 98101, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

294

Study ID:

NCT01301157

Recruitment Status:

Completed

Sponsor:


Maruho Co., Ltd.

How clear is this clinincal trial information?

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