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

Completed · Phase 2 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT01301157

Run by

Maruho Co., Ltd.

People needed

294

Starts

2011-02-01

Last updated by the study team

2015-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.