Plaque Psoriasis
Conditions
Brief summary
This study is to investigate the efficacy and safety of M518101 in male and female plaque psoriasis patients with refractory plaques.
Interventions
DRUGM518101
Proper quantity twice a day
DRUGplacebo
Proper quantity twice a day
Sponsors
Maruho Co., Ltd.
Study design
Allocation
RANDOMIZED
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of plaque psoriasis | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigator and Patient overall assessment | — |
Countries
United Kingdom
Outcome results
None listed