Long Term Study to Evaluate Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | August 2013 |
End Date: | May 2015 |
An Open-label, Multi-center, Long-term Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis
This study is to evaluate the efficacy and safety for long term use of M518101 in subjects
with plaque psoriasis.
with plaque psoriasis.
Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
31
sites
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New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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South Bend Clinic The South Bend Clinic employs a staff of 610 at its five...
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PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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