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

Phase 2

Completed

• Conditions: Plaque Psoriasis

• Registration Number: NCT00884169
• Lead Sponsor: Maruho Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-17
• Study First Submitted QC: 2009-04-17
• Study First Posted: 2009-04-20
• Study Start: 2009-07
• Study Completion: 2009-12
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-02
• Last Update Posted: 2010-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of plaque psoriasis

Secondary Outcome Measures

Name	Time	Method
Investigator and Patient overall assessment

Trial Locations

Locations (1)

St Thomas' Hospital; 🇬🇧 London, United Kingdom