Status:
COMPLETED
Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis
Lead Sponsor:
Maruho North America Inc.
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is to evaluate the efficacy and safety of M518101 in subjects with plaque psoriasis
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
542 Patients enrolled
Trial Details
Trial ID
NCT01878461
Start Date
June 1 2013
End Date
May 1 2015
Last Update
September 2 2015
Active Locations (34)
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1
Agave Clinical Research
Mesa, Arizona, United States, 85202
2
T Joseph Raoof
Encino, California, United States, 91436
3
Medical Center for Clinical Research
San Diego, California, United States, 92108
4
Therapeutics Clinical Research
San Diego, California, United States, 92123