Overview

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

Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
0
Participant gender:
All
Summary
This study is to evaluate the efficacy and safety 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 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.