A Randomized, Vehicle Controlled, Double Blind, Parallel Group, Multi Center Phase III Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis

Maruho North America Inc.30 sites in 1 country537 target enrollmentJune 2013

ConditionsPsoriasis

Overview

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

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

April 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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.

•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.