Long Term Study to Evaluate Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis

Maruho

Status and phase

Completed

Phase 3

Conditions

Psoriasis

Treatments

Drug: M518101

Study type

Interventional

Funder types

Industry

Identifiers

M518101-US04

Details and patient eligibility

About

This study is to evaluate the efficacy and safety for long term use of M518101 in subjects with plaque psoriasis.

Enrollment

480 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.