Status:
COMPLETED
Study to Investigate the Efficacy and the Safety of M518101 in Psoriasis Patients
Lead Sponsor:
Maruho Co., Ltd.
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study is to investigate the efficacy and safety of M518101 in male and female plaque psoriasis patients with refractory plaques.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
End Date :
December 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00884169
Start Date
July 1 2009
End Date
December 1 2009
Last Update
November 3 2010
Active Locations (1)
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1
St Thomas' Hospital
London, United Kingdom, SE1 7EH