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

NCT00884169 | Completed Phase 2

• 1 other identifier: M518101-EU03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Severity of plaque psoriasis

Secondary Outcomes (1)

• Investigator and Patient overall assessment

Interventions

M518101 DRUG

Proper quantity twice a day

placebo DRUG

Proper quantity twice a day

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maruho Co., Ltd.: lead

Study Sites (1)

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 17, 2009
• First Posted: April 20, 2009
• Study Start: July 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 3, 2010

Record last verified: 2010-11

Locations

GB (1)