Long Term Study to Evaluate Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis

This is an interventional treatment trial for Psoriasis Read More

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.