Clinical trial NCT01301157: Study to Investigate the Efficacy and the Safety of M518101 in Plaque Psoriasis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: severity of plaque psoriasis
timeFrame: 8 weeks after dosing
Secondary outcomes:
measure: Investigator global assessment
timeFrame: 8 weeks after dosing
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama (UAB) Dermatology
state: Alabama
city: Mobile
country: United States
facility: Coastal Carolina Research
state: Alabama
city: Fresno
country: United States
facility: Sierra Medical Research
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Santa Monica,
country: United States
facility: Clinical Science Institute
state: California
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Jacsonville
country: United States
facility: Ameriderm Research
state: Florida
city: Ormond Beach
country: United States
facility: Ameriderm Research
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein & Research Ctr
state: Georgia
city: Skokie
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: South Bend
country: United States
facility: The Southbend Clinic, LLC
state: Indiana
city: Louisville
country: United States
facility: Derm Research
state: Kentucky
city: Baton Rouge
country: United States
facility: Medical Development Centers, LLC
state: Louisiana
city: Opelousas
country: United States
facility: Medical Development Centers, LLC
state: Louisiana
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Saint Louis
country: United States
facility: Washington University, Dermatology Clinical Trials Unit
state: Missouri
city: St. Louis
country: United States
facility: Central Dermatology
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center, Section of Dermatology
state: New Hampshire
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc.
state: New York
city: Stony Brook
country: United States
facility: DermResearchCenter of New York, Inc
state: New York
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Dermatology Center
state: North Carolina
city: Columbus
country: United States
facility: Radiant Research
state: Ohio
city: Oklahoma
country: United States
facility: OUHSC-Dermatology
state: Oklahoma
city: Lake Oswego
country: United States
facility: Baker Allergy, Asthma and Dermatology Research Center, LLC
state: Oregon
city: Greenville
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Arlington
country: United States
facility: Arlington Research Center, Inc
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies, Texas Medical Center
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research Inc.
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates
state: Washington
Study officials:
References: