Skip to main content
OpenTrials
Completed

NCT Number: NCT01878461

Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Agave Clinical Research, Mesa, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vehicle

Drug

M518101

Drug

Primary outcomes

  1. Investigator Global Assessment

    Time frame: 8 weeks after dosing

Sponsors and collaborators

Lead sponsor

Maruho North America Inc.

Industry

Registry information

Official study title

A Randomized, Vehicle Controlled, Double Blind, Parallel Group, Multi Center PhaseIII Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 17, 2013
Registry last updated
Sep 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.