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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873677
• Other study ID #: M518101-US02
• Status: Completed
• Phase: Phase 3
• First received: June 6, 2013
• Last updated: August 14, 2015
• Start date: June 2013
• Est. completion date: April 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 of M518101 in subjects with plaque psoriasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 537
• Est. completion date: April 2015
• Est. primary completion date: April 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 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• M518101

• Vehicle

Locations

Country	Name	City	State
United States	Visions Clinical Research	Boynton Beach	Florida
United States	PMG research of Raleigh	Cary	North Carolina
United States	Radiant Research	Edina	Minnesota
United States	Philadelphia Institute of Dermatology	Fort Washington	Pennsylvania
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Radiant Research	Greer	South Carolina
United States	Derm Dox Center for Dermatology	Hazelton	Pennsylvania
United States	The Center for Skin Research	Houston	Texas
United States	Dawes Fretzin Clinical Research Group	Indianapolis	Indiana
United States	North Florida Dermatology Associates	Jacksonville	Florida
United States	Clinical Partners	Johnston	Rhode Island
United States	Suzanne Bruce and Associates The Center for Skin Research	Katy	Texas
United States	Shondra Smith Dermatology & Advanced Aesthetics	Lake Charles	Louisiana
United States	International Dermatology Research Inc	Miami	Florida
United States	FXM Research Miramar	Miramar	Florida
United States	Coastal Clinical Research	Mobile	Alabama
United States	The Savin Center	New Haven	Connecticut
United States	Renstar Medical Research	Ocala	Florida
United States	Oklahoma University Health Science Center	Oklahoma City	Oklahoma
United States	Omni Dermatology	Phoenix	Arizona
United States	Belleair Research Center	Pinellas Park	Florida
United States	The Indiana Clinical Trials Center	Plainfield	Indiana
United States	Rhode Island Hospital Dermatology	Providence	Rhode Island
United States	Dermatology Clinical Res.	San Antonio	Texas
United States	Skin Surgery Medical Group	San Diego	California
United States	University Clinical Trials	San Diego	California
United States	Dermatology Associates	Seattle	Washington
United States	Olympian Clinical Research	Tampa	Florida
United States	Center for Clinical Studies	Webster	Texas
United States	Atlantic Dermatology Associates	Wilmington	North Carolina
United States	Wake Forest University	Winston Salem	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	Investigator Global Assessment		8 weeks after dosing	No