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

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the efficacy and safety for long term use of M518101 in subjects with plaque psoriasis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maruho North America Inc.

Criteria

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.