Study to Investigate the Efficacy and the Safety of M518101 in Plaque Psoriasis Patients
1 other identifier
interventional
294
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 18, 2011
CompletedFirst Posted
Study publicly available on registry
February 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedNovember 5, 2015
October 1, 2015
11 months
February 18, 2011
October 12, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
severity of plaque psoriasis
8 weeks after dosing
Secondary Outcomes (1)
Investigator global assessment
8 weeks after dosing
Study Arms (4)
25ug M518101
EXPERIMENTALVehicle
PLACEBO COMPARATORDovonex
ACTIVE COMPARATOR50ug M518101
EXPERIMENTALInterventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maruho Co., Ltd.lead
Study Sites (32)
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
Central Dermatology
St Louis, Missouri, 63117, United States
Washington University, Dermatology Clinical Trials Unit
St Louis, Missouri, 63141, 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 City, 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
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2011
First Posted
February 23, 2011
Study Start
February 1, 2011
Primary Completion
January 1, 2012
Last Updated
November 5, 2015
Record last verified: 2015-10