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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2

Details

• Lead Sponsor: Maruho Co., Ltd.

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• Who have been treated with topical therapy during the wash-out and lead-in period.