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

Sponsored by Maruho Co., Ltd.

Phase Quota
Phase 2

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.

Study Start Date: February 2011

Estimated Completion Date: January 2012

Specialties: Internal Medicine: Dermatology Family Medicine: Dermatology Dermatology: Psoriasis

Interventions

  • Drug: Dovonex
  • Drug: M518101
  • Drug: placebo

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 Locations And Contact Information

  • Dermatology Associates, Seattle Washington
  • Baker Allergy, Asthma and Dermatology Research Center, LLC, Lake Oswego Oregon
  • Atlanta Dermatology, Vein & Research Ctr, Alpharetta Georgia
  • Washington University, Dermatology Clinical Trials Unit, Saint Louis Missouri
  • Medical Development Centers, LLC, Baton Rouge Louisiana
  • Wilmington Dermatology Center, Wilmington North Carolina
  • Arlington Research Center, Inc, Arlington Texas
  • University of Alabama (UAB) Dermatology, Birmingham Alabama
  • Dermatology Consulting Services, High Point North Carolina
  • Central Dermatology, St. Louis Missouri
  • Derm Research, Louisville Kentucky
  • Radiant Research, Columbus Ohio
  • Ameriderm Research, Jacsonville Florida
  • Ameriderm Research, Ormond Beach Florida
  • Palmetto Clinical Trial Services, LLC, Greenville South Carolina
  • NorthShore University HealthSystem, Skokie Illinois
  • Sierra Medical Research, Fresno California
  • OUHSC-Dermatology, Oklahoma Oklahoma
  • Hamzavi Dermatology, Fort Gratiot Michigan
  • The Southbend Clinic, LLC, South Bend Indiana
  • Medical Development Centers, LLC, Opelousas Louisiana
  • Therapeutics Clinical Research, San Diego California
  • Skin Search of Rochester, Inc., Rochester New York
  • Dartmouth-Hitchcock Medical Center, Section of Dermatology, Lebanon New Hampshire
  • Coastal Carolina Research, Mobile Alabama
  • Dermatology Clinical Research Center, San Antonio Texas
  • DermResearchCenter of New York, Inc, Stony Brook New York
  • Dawes Fretzin Clinical Research Group, LLC, Indianapolis Indiana
  • Visions Clinical Research, Boynton Beach Florida
  • Virginia Clinical Research Inc., Norfolk Virginia
  • Clinical Science Institute, Santa Monica, California
  • Center for Clinical Studies, Texas Medical Center, Houston Texas

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