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

Phase 2

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: Dovonex; Drug: M518101; Drug: placebo

• Registration Number: NCT01301157
• Lead Sponsor: Maruho Co., Ltd.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-18
• Study First Submitted QC: 2011-02-18
• Study First Posted: 2011-02-23
• Primary Completion: 2012-01
• Status Verified: 2015-10
• Disposition First Submitted: 2015-10-12
• Disposition First Submitted QC: 2015-10-12
• Last Update Submitted: 2015-10-12
• Disposition First Posted: 2015-11-05
• Last Update Posted: 2015-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

Inclusion Criteria

1. Who are able and willing to give signed informed consent
2. Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator.
3. Who have less than 20% of body surface area (BSA) afflicted with plaques
4. Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.

Exclusion Criteria

1. Who have a history of allergy to vitamin D3 derivative preparations.
2. Who have a history of relevant drug hypersensitivity.
3. Who have a history of contact dermatitis induced by a topical medicine.
4. Who are pregnant or lactating.
5. Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
6. Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
7. 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.
8. Whose serum calcium levels exceed the upper limit of reference range
9. Who have used any investigational medicinal product and/or participated in any clinical study within 60 days before the day of signing the ICF.
10. Who have been treated with systemic therapy within 2 weeks before the day of signing the ICF and during the wash-out period.
11. Who have been treated with biologics within 5 half-lives of the biologics before the day of randomization.
12. Who have been treated with topical therapy during the wash-out period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dovonex	Dovonex	-
25ug M518101	M518101	-
Vehicle	placebo	-
50ug M518101	M518101	-

Primary Outcome Measures

Name	Time	Method
severity of plaque psoriasis	8 weeks after dosing

Secondary Outcome Measures

Name	Time	Method
Investigator global assessment	8 weeks after dosing

Trial Locations

Locations (30)

Sierra Medical Research; 🇺🇸 Fresno, California, United States

DermResearchCenter of New York, Inc; 🇺🇸 Stony Brook, New York, United States

University of Alabama (UAB) Dermatology; 🇺🇸 Birmingham, Alabama, United States

Coastal Carolina Research; 🇺🇸 Mobile, Alabama, United States

Clinical Science Institute; 🇺🇸 Santa Monica,, California, United States

Visions Clinical Research; 🇺🇸 Boynton Beach, Florida, United States

NorthShore University HealthSystem; 🇺🇸 Skokie, Illinois, United States

Atlanta Dermatology, Vein & Research Ctr; 🇺🇸 Alpharetta, Georgia, United States

Dawes Fretzin Clinical Research Group, LLC; 🇺🇸 Indianapolis, Indiana, United States

The Southbend Clinic, LLC; 🇺🇸 South Bend, Indiana, United States

Washington University, Dermatology Clinical Trials Unit; 🇺🇸 Saint Louis, Missouri, United States

Derm Research; 🇺🇸 Louisville, Kentucky, United States

Central Dermatology; 🇺🇸 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

Dermatology Consulting Services; 🇺🇸 High Point, North Carolina, United States

OUHSC-Dermatology; 🇺🇸 Oklahoma, Oklahoma, United States

Wilmington Dermatology Center; 🇺🇸 Wilmington, North Carolina, United States

Arlington Research Center, Inc; 🇺🇸 Arlington, Texas, United States

Baker Allergy, Asthma and Dermatology Research Center, LLC; 🇺🇸 Lake Oswego, Oregon, United States

Virginia Clinical Research Inc.; 🇺🇸 Norfolk, Virginia, United States

Center for Clinical Studies, Texas Medical Center; 🇺🇸 Houston, Texas, United States

Dermatology Associates; 🇺🇸 Seattle, Washington, United States

Dermatology Clinical Research Center; 🇺🇸 San Antonio, Texas, United States

Ameriderm Research; 🇺🇸 Ormond Beach, Florida, United States

Hamzavi Dermatology; 🇺🇸 Fort Gratiot, Michigan, United States

Medical Development Centers, LLC; 🇺🇸 Opelousas, Louisiana, United States

Palmetto Clinical Trial Services, LLC; 🇺🇸 Greenville, South Carolina, United States

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States

Radiant Research; 🇺🇸 Columbus, Ohio, United States