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

Plaque Psoriasis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884169
• Other study ID #: M518101-EU03
• Status: Completed
• Phase: Phase 2
• First received: April 17, 2009
• Last updated: November 2, 2010
• Start date: July 2009
• Est. completion date: December 2009

Study information

• Verified date: November 2010
• Source: Maruho Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of PharmacyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyCzech Republic: State Institute for Drug ControlPoland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2009
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Masking: Double-Blind

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• M518101
Proper quantity twice a day
• placebo
Proper quantity twice a day

Locations

Country	Name	City	State
United Kingdom	St Thomas' Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Maruho Co., Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of plaque psoriasis
Secondary	Investigator and Patient overall assessment