Study to Investigate the Efficacy and the Safety of M518101 in Plaque Psoriasis Patients

Plaque Psoriasis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01301157
• Other study ID #: M518101-US01
• Status: Completed
• Phase: Phase 2
• First received: February 18, 2011
• Last updated: October 12, 2015
• Start date: February 2011

Study information

• Verified date: October 2015
• Source: Maruho Co., Ltd.
• 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 and the dose relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients.

Description:

This study is to evaluate the efficacy and safety of M518101 and the dose response relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients and to confirm the persistence of the effect of M518101.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Who are able and willing to give signed informed consent

2. Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator.

3. Who have less than 20% of body surface area (BSA) afflicted with plaques

4. Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.

Exclusion Criteria:

1. Who have a history of allergy to vitamin D3 derivative preparations.

2. Who have a history of relevant drug hypersensitivity.

3. Who have a history of contact dermatitis induced by a topical medicine.

4. Who are pregnant or lactating.

5. Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.

6. Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.

7. 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.

8. Whose serum calcium levels exceed the upper limit of reference range

9. Who have used any investigational medicinal product and/or participated in any clinical study within 60 days before the day of signing the ICF.

10. Who have been treated with systemic therapy within 2 weeks before the day of signing the ICF and during the wash-out period.

11. Who have been treated with biologics within 5 half-lives of the biologics before the day of randomization.

12. Who have been treated with topical therapy during the wash-out period.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• M518101
Proper quantity twice a day
• placebo
Proper quantity twice a day
• Dovonex
Proper quantity twice a day

Locations

Country	Name	City	State
United States	Atlanta Dermatology, Vein & Research Ctr	Alpharetta	Georgia
United States	Arlington Research Center, Inc	Arlington	Texas
United States	Medical Development Centers, LLC	Baton Rouge	Louisiana
United States	University of Alabama (UAB) Dermatology	Birmingham	Alabama
United States	Visions Clinical Research	Boynton Beach	Florida
United States	Radiant Research	Columbus	Ohio
United States	Hamzavi Dermatology	Fort Gratiot	Michigan
United States	Sierra Medical Research	Fresno	California
United States	Palmetto Clinical Trial Services, LLC	Greenville	South Carolina
United States	Dermatology Consulting Services	High Point	North Carolina
United States	Center for Clinical Studies, Texas Medical Center	Houston	Texas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Ameriderm Research	Jacsonville	Florida
United States	Baker Allergy, Asthma and Dermatology Research Center, LLC	Lake Oswego	Oregon
United States	Dartmouth-Hitchcock Medical Center, Section of Dermatology	Lebanon	New Hampshire
United States	Derm Research	Louisville	Kentucky
United States	Coastal Carolina Research	Mobile	Alabama
United States	Virginia Clinical Research Inc.	Norfolk	Virginia
United States	OUHSC-Dermatology	Oklahoma	Oklahoma
United States	Medical Development Centers, LLC	Opelousas	Louisiana
United States	Ameriderm Research	Ormond Beach	Florida
United States	Skin Search of Rochester, Inc.	Rochester	New York
United States	Washington University, Dermatology Clinical Trials Unit	Saint Louis	Missouri
United States	Dermatology Clinical Research Center	San Antonio	Texas
United States	Therapeutics Clinical Research	San Diego	California
United States	Clinical Science Institute	Santa Monica,	California
United States	Dermatology Associates	Seattle	Washington
United States	NorthShore University HealthSystem	Skokie	Illinois
United States	The Southbend Clinic, LLC	South Bend	Indiana
United States	Central Dermatology	St. Louis	Missouri
United States	DermResearchCenter of New York, Inc	Stony Brook	New York
United States	Wilmington Dermatology Center	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Maruho Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of plaque psoriasis		8 weeks after dosing	No
Secondary	Investigator global assessment		8 weeks after dosing	No