Long Term Study to Evaluate Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis
An Open-label, Multi-center, Long-term Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis
1 other identifier
interventional
480
1 country
31
Brief Summary
This study is to evaluate the efficacy and safety for long term use of M518101 in subjects with plaque psoriasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2013
31 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
First Submitted
Initial submission to the registry
July 23, 2013
CompletedFirst Posted
Study publicly available on registry
July 25, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedSeptember 2, 2015
August 1, 2015
1.7 years
July 23, 2013
August 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Time course change of Investigator Global Assessment
4 weeks interval
Study Arms (1)
M518101
EXPERIMENTALProper quantity twice daily
Interventions
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 up to 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 or a history of relevant drug hypersensitivity.
- 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 of treatment.
- Who have been treated with systemic therapy within 30days of treatment.
- Who have treated with biologics within 5 half-lives of the biologics before the day of treatment
- Who have been treated with topical therapy within 14days before the day of treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Agave Clinical Research
Mesa, Arizona, 85202, United States
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, 93309, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
ATS Clinical Research
Santa Monica, California, 90404, United States
Horizons Clinical Research Center
Denver, Colorado, 80220, United States
Dermatology and Aesthetic Center Skin Care
Boca Raton, Florida, 33486, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
FXM Research Miramar
Miramar, Florida, 33027, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
USF Health Morsani Center for Advanced Healthcare
Tampa, Florida, 33612, United States
Peachtree Dermatology Associates Research Center
Atlanta, Georgia, 30327, United States
Northshore University Health System
Skokie, Illinois, 60077, United States
South bend clinic
South Bend, Indiana, 46617, United States
Kansas City Dermatology
Overland Park, Kansas, 66215, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
J Woodson Dermatology and Associates
Henderson, Nevada, 89074, United States
New York University
New York, New York, 10016, United States
PMG research of raleigh
Cary, North Carolina, 27518, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
Radiant Research
Cincinnati, Ohio, 45249, United States
Bager Allergy, Asthma and Dermatology Research Center
Lake Oswego, Oregon, 97035, United States
PMG Research of Bristol
Kingsport, Tennessee, 37660, United States
Dermatology Associates of Knoxville
Knoxville, Tennessee, 37917, United States
The skin wellness center
Knoxville, Tennessee, 37922, United States
Suzanne Bruce & Associates
Houston, Texas, 77056, United States
Research Across America
Plano, Texas, 75093, United States
Progressive Clinical Research
San Antonio, Texas, 78229, United States
Stephen Miller
San Antonio, Texas, 78249, United States
Dermatology Research Center
Salt Lake City, Utah, 84117, United States
Madison Skin & Research
Madison, Wisconsin, 53719, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2013
First Posted
July 25, 2013
Study Start
August 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
September 2, 2015
Record last verified: 2015-08