Study to Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis
A Randomized, Vehicle Controlled, Double Blind, Parallel Group, Multi Center Phase III Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis
1 other identifier
interventional
537
1 country
31
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
31 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 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedSeptember 2, 2015
August 1, 2015
1.8 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 (31)
Coastal Clinical Research
Mobile, Alabama, 36608, United States
Omni Dermatology
Phoenix, Arizona, 85018, United States
Skin Surgery Medical Group
San Diego, California, 92117, United States
University Clinical Trials
San Diego, California, 92123, United States
The Savin Center
New Haven, Connecticut, 06511, United States
Visions Clinical Research
Boynton Beach, Florida, 33472, United States
North Florida Dermatology Associates
Jacksonville, Florida, 32204, United States
International Dermatology Research Inc
Miami, Florida, 33144, United States
FXM Research Miramar
Miramar, Florida, 33027, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Belleair Research Center
Pinellas Park, Florida, 33781, United States
Olympian Clinical Research
Tampa, Florida, 33609, United States
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46256, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168, United States
Shondra Smith Dermatology & Advanced Aesthetics
Lake Charles, Louisiana, 70605, United States
Radiant Research
Edina, Minnesota, 55435, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
PMG research of Raleigh
Cary, North Carolina, 27518, United States
Atlantic Dermatology Associates
Wilmington, North Carolina, 28401, United States
Wake Forest University
Winston-Salem, North Carolina, 27104, United States
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, 19034, United States
Derm Dox Center for Dermatology
Hazleton, Pennsylvania, 18201, United States
Clinical Partners
Johnston, Rhode Island, 02919, United States
Rhode Island Hospital Dermatology
Providence, Rhode Island, 02903, United States
Radiant Research
Greer, South Carolina, 29650, United States
The Center for Skin Research
Houston, Texas, 77056, United States
Suzanne Bruce and Associates The Center for Skin Research
Katy, Texas, 77494, United States
Dermatology Clinical Res.
San Antonio, Texas, 78229, United States
Center for Clinical Studies
Webster, Texas, 77598, United States
Dermatology Associates
Seattle, Washington, 98101, 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 10, 2013
Study Start
June 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
September 2, 2015
Record last verified: 2015-08