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

Psoriasis Clinical Trial

Official title:

An Open-label, Multi-center, Long-term Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908595
• Other study ID #: M518101-US04
• Status: Completed
• Phase: Phase 3
• First received: July 23, 2013
• Last updated: August 14, 2015
• Start date: August 2013
• Est. completion date: May 2015

Study information

• Verified date: August 2015
• Source: Maruho North America Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• M518101

Locations

Country	Name	City	State
United States	Peachtree Dermatology Associates Research Center	Atlanta	Georgia
United States	Bakersfield Dermatology and Skin Cancer Medical Group	Bakersfield	California
United States	Dermatology and Aesthetic Center Skin Care	Boca Raton	Florida
United States	PMG research of raleigh	Cary	North Carolina
United States	Radiant Research	Cincinnati	Ohio
United States	Horizons Clinical Research Center	Denver	Colorado
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	J Woodson Dermatology and Associates	Henderson	Nevada
United States	Suzanne Bruce & Associates	Houston	Texas
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	PMG Research of Bristol	Kingsport	Tennessee
United States	Dermatology Associates of Knoxville	Knoxville	Tennessee
United States	The skin wellness center	Knoxville	Tennessee
United States	Bager Allergy, Asthma and Dermatology Research Center	Lake Oswego	Oregon
United States	Dermatology Research Associates	Los Angeles	California
United States	Madison Skin & Research	Madison	Wisconsin
United States	Agave Clinical Research	Mesa	Arizona
United States	FXM Research Miramar	Miramar	Florida
United States	New York University	New York	New York
United States	Renstar Medical Research	Ocala	Florida
United States	Kansas City Dermatology	Overland Park	Kansas
United States	Research Across America	Plano	Texas
United States	Dermatology Research Center	Salt Lake City	Utah
United States	Progressive Clinical Research	San Antonio	Texas
United States	Stephen Miller	San Antonio	Texas
United States	Medical Center for Clinical Research	San Diego	California
United States	ATS Clinical Research	Santa Monica	California
United States	Northshore University Health System	Skokie	Illinois
United States	South bend clinic	South Bend	Indiana
United States	USF Health Morsani Center for Advanced Healthcare	Tampa	Florida
United States	PMG Research of Wilmington	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Maruho North America Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time course change of Investigator Global Assessment		4 weeks interval	No