Overview

This trial is active, not recruiting.

Condition psoriasis
Treatments m518101, vehicle
Phase phase 3
Sponsor Maruho North America Inc.
Start date June 2013
End date September 2015
Trial size 522 participants
Trial identifier NCT01873677, M518101-US02

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
Proper quantity twice a day
vehicle
(Experimental)
Proper quantity twice a day
m518101

Primary Outcomes

Measure
Investigator Global Assessment
time frame: 8 weeks after dosing

Eligibility Criteria

Male or female participants at least 18 years old.

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 randomization. - Who have been treated with systemic therapy within 30days of randomization. - Who have treated with biologics within 5 half-lives of the biologics before the day of randomization - Who have been treated with topical therapy within 14days before the day of randomization.

Additional Information

Official title A Randomized, Vehicle Controlled, Double Blind, Parallel Group, Multi Center Phase III Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Maruho North America Inc..