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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Blinding Strategy

DOUBLE

Interventions

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M518101

Proper quantity twice a day

Intervention Type DRUG

placebo

Proper quantity twice a day

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Maruho Co.,Ltd ・Kyoto R&D Center

Locations

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St Thomas' Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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M518101-EU03

Identifier Type: -

Identifier Source: org_study_id