Study to Investigate the Efficacy and the Safety of M518101 in Psoriasis Patients

Maruho Co., Ltd.1 site in 1 countryJuly 2009

Overview

This study is to investigate the efficacy and safety of M518101 in male and female plaque psoriasis patients with refractory plaques.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

December 2009

Last Updated

15 years ago

Study Type

Interventional

Sex

All

Sponsor

•Who are able and willing to give signed informed consent
•Who are male or females aged between 18 and 65 years with plaque psoriasis confirmed by the Investigator.
•Who have less than 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.
•Who have a history of relevant drug hypersensitivity.
•Who have a history of contact dermatitis induced by a topical medicine.
•Who are pregnant or lactating.
•Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
•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 24 weeks
•Who have been treated with systemic therapy within 8 weeks
•Who have been treated with biologics within 12 weeks