Psoriasis
Conditions
Brief summary
This study is to evaluate the efficacy and safety for long term use of M518101 in subjects with plaque psoriasis.
Interventions
DRUGM518101
Sponsors
Maruho North America Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Who are able and willing to give signed informed consent * Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator. * Who have up to 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 or a history of relevant drug hypersensitivity. * Who are pregnant or lactating. * Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease. * Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests. * 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 60 days of treatment. * Who have been treated with systemic therapy within 30days of treatment. * Who have treated with biologics within 5 half-lives of the biologics before the day of treatment * Who have been treated with topical therapy within 14days before the day of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time course change of Investigator Global Assessment | 4 weeks interval |
Countries
United States
Outcome results
None listed