Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis
A Randomized, Vehicle Controlled, Double Blind, Parallel Group, Multi Center PhaseIII Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis
1 other identifier
interventional
542
1 country
34
Brief Summary
This study is to evaluate the efficacy and safety 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 P75+ for phase_3
Started Jun 2013
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 6, 2013
CompletedFirst Posted
Study publicly available on registry
June 17, 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
1.9 years
June 6, 2013
August 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Investigator Global Assessment
8 weeks after dosing
Study Arms (2)
Vehicle
PLACEBO COMPARATORProper quantity twice a day
M518101
EXPERIMENTALProper quantity twice a day
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 randomization.
- Who have been treated with systemic therapy within 30days of randomization.
- Who have treated with biologics within 5 half-lives of the biologics before the day of randomization
- Who have been treated with topical therapy within 14days before the day of randomization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Agave Clinical Research
Mesa, Arizona, 85202, United States
T Joseph Raoof
Encino, California, 91436, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Horizons Clinical Research Center
Denver, Colorado, 80220, United States
The Center for Clinical and Cosmetic Research
Aventura, Florida, 33180, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, 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
Derm Research
Louiville, Kentucky, 40217, United States
Dermatology Specialists Research
Lousville, Kentucky, 40202, United States
Medical Development Center
Baton Rouge, Louisiana, 70808, United States
Grekin Skin Institute
Warren, Michigan, 48088, United States
Washington University Dermatology
St Louis, Missouri, 63141, United States
Karl G Heine Dermatology
Henderson, Nevada, 89052, United States
Las Vegas Skin and Cancer Center
Las Vegas, Nevada, 89106, United States
Center of Central New Jersey
East Windsor, New Jersey, 08520, United States
Skin Search of Rochester
Rochester, New York, 14623, United States
Derm Research Center of New York
Stony Brook, New York, 11790, United States
PMG Research of Charlotte
Charlotte, North Carolina, 28209, United States
Dermatology Consulting Services
High Point, North Carolina, 27262, United States
Medical Development Center
Wilmington, North Carolina, 28403, United States
Radiant Research
Cincinnati, Ohio, 45249, United States
Central Sooner Research
Norman, Oklahoma, 73071, United States
Palmetto Clinical Trial Servises
Fountain Inn, South Carolina, 29644, United States
Coastal Clinical Research Center
Mt. Pleasant, South Carolina, 29464, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
Austin Dermatology Associates
Austin, Texas, 78705, United States
DermResearch
Austin, Texas, 78759, United States
Menter Dermatology Research Institute
Dallas, Texas, 75246, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Dermatology Research Center
Salt Lake City, Utah, 84117, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2013
First Posted
June 17, 2013
Study Start
June 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
September 2, 2015
Record last verified: 2015-08