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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Maruho North America Inc.

ClinicalTrials.gov Identifier:

NCT01908595

First received: July 23, 2013

Last updated: August 14, 2015

Last verified: August 2015

History of Changes

Purpose

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

Condition	Intervention	Phase
Psoriasis	Drug: M518101	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-label, Multi-center, Long-term Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Maruho North America Inc.:

Primary Outcome Measures:

Time course change of Investigator Global Assessment [ Time Frame: 4 weeks interval ]


Enrollment:	480
Study Start Date:	August 2013
Study Completion Date:	May 2015
Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: M518101 Proper quantity twice daily	Drug: M518101

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01908595

Show 31 Study Locations

Sponsors and Collaborators

Maruho North America Inc.

More Information


Responsible Party:	Maruho North America Inc.
ClinicalTrials.gov Identifier:	NCT01908595 History of Changes
Other Study ID Numbers:	M518101-US04
Study First Received:	July 23, 2013
Last Updated:	August 14, 2015

Additional relevant MeSH terms:


Psoriasis Skin Diseases, Papulosquamous Skin Diseases

ClinicalTrials.gov processed this record on July 17, 2017

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