A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis
- Registration Number
- NCT00540618
- Lead Sponsor
- MedImmune LLC
- Brief Summary
To compare disease activity, as measured by PASI score, of three MEDI-507 dosing (injection)regimens vs. placebo.
- Detailed Description
The primary objective of this study is to compare disease activity, as measured by PASI score, of three MEDI-507 dosing regimens (5 mg for 12 weeks, 5 mg for 6 weeks, 7 mg for 4 weeks) versus placebo administered weekly by SC injection.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 420
- Plaque psoriasis involving at least 10% of body surface area
- Age 18 through 65 years at the time of the first dose of study drug
- Both males and females are eligible. However, sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 30 days prior to the first dose of study drug and must agree to continue
- Currently receiving no therapy for psoriasis except emollients (certain other over-the-counter products may be allowed with prior approval of the sponsor)
- Written informed consent obtained from the patient
- Ability to complete follow-up period of 167 days as required by the protocol
- Pustular, guttate, or erythrodermic psoriasis as the predominant disease type
- PASI score <8
- At screening (must be within 21 days before study entry) any of the following: lymphocyte count under 1,200 cells/mm3, WBC under 4,000 cells/mm3, hematocrit below 32%, platelets below 110,000 cells/mm3, creatinine, AST, ALT over 1.5 times upper limit of normal
- At screening (must be within 21 days before study entry) any clinical evidence of HIV, hepatitis B, hepatitis C or active hepatitis A infection
- Pregnancy (must have a negative serum pregnancy test within 21 days prior to the first dose of study drug, and urine pregnancy test must be negative on Study Day 0 before study entry)
- History of cancer (except excision of basal cell carcinoma)
- Any documented immunodeficiency
- A history of prior administration of monoclonal antibodies or related proteins
- Receipt of systemic retinoids, corticosteroids, cyclosporin A, methotrexate, phototherapy or coal tar treatment in the past 4 weeks
- Use of topical therapy (except emollients) for psoriasis in the past 2 weeks (certain other over-the-counter products may be allowed with prior approval of the sponsor)
- Receipt of any investigational drug therapy within 6 weeks before the first dose of study drug in this protocol (use of licensed agents for indications not listed in the package insert is permitted)
- Current or planned participation in a research protocol in which an investigational agent or therapy may be administered
- Nursing mother
- Acute illness including infections 15. Clinical manifestations of significant end organ dysfunction or failure that may compromise the safety of the volunteer in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 MEDI-507 MEDI-507 2 Placebo - 3 MEDI-507 MEDI-507 4 MEDI-507 MEDI-507
- Primary Outcome Measures
Name Time Method Biological activity will be assessed primarily by the Psoriasis Activity and Severity Index (PASI) Days 14, 28, 42, 56, 70, 91, 107, and 167
- Secondary Outcome Measures
Name Time Method Observe adverse and serious adverse events Day 107 and 167
Trial Locations
- Locations (42)
The South Bend Clinic
🇺🇸South Bend, Indiana, United States
nTouch Research Corporation
🇺🇸San Diego, California, United States
Northwestern University Medical School
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dermatology Clinical Research Center of San Antonio
🇺🇸San Antonio, Texas, United States
Queen Elizabeth II Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
Harmony Clinical Research, Inc.
🇺🇸Johnson City, Tennessee, United States
Northeast Clinical Research Center
🇺🇸Allentown, Pennsylvania, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
The Dermatology Centre
🇨🇦Calgary, Alberta, Canada
Clinicalm Partners-LLC
🇺🇸Johnston, Rhode Island, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
University Dermatology Consultants, Inc.
🇺🇸Cincinnatti, Ohio, United States
NewLab Clinical Research
🇨🇦St. Johns, Newfoundland and Labrador, Canada
Breco Research, Ltd.
🇺🇸Houston, Texas, United States
Innovaderm Research Inc.
🇨🇦Montreal, Quebec, Canada
Dermatology Consultants, PC
🇺🇸Nashville, Tennessee, United States
MDS Pharma Services (US) Inc.
🇺🇸Phoenix, Arizona, United States
Veteran's Administration Medical Center
🇺🇸Nashville, Tennessee, United States
International Dermatology Research
🇨🇦Montreal, Quebec, Canada
Colorado Medical Research Center, Inc.
🇺🇸Denver, Colorado, United States
Oregon Medical Research Center, PC
🇺🇸Portland, Oregon, United States
Bressinck-Parker-Dinehart-Sangster Dermatology, PA
🇺🇸Little Rock, Arkansas, United States
Solano Clinical Research
🇺🇸Vallejo, California, United States
Dermatology Specialists, Inc.
🇺🇸Vista, California, United States
The Savin Center, PC
🇺🇸New Haven, Connecticut, United States
North Florida Dermatology Associates, PA
🇺🇸Jacksonville, Florida, United States
Comprehensive Research Institute
🇺🇸Tampa, Florida, United States
Atlanta Dermatology, Vein & Research Center, LLC
🇺🇸Alpharetta, Georgia, United States
Research Solutions, LLC
🇺🇸Evansville, Indiana, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Associates in Dermatology Research
🇺🇸Rutherford, New Jersey, United States
Sadick Research Group
🇺🇸New York, New York, United States
FutureCare Studies
🇺🇸Springfield, Massachusetts, United States
Probe Inc.
🇺🇸Delran, New Jersey, United States
Paddington Testing Company
🇺🇸Philadelphia, Pennsylvania, United States
ICSL-Clinical Studies
🇺🇸Sarasota, Florida, United States
University of Medicine & Dentistry of New Jersey Robert Wood Johnson Medical School and Clinical Research Center
🇺🇸New Brunswick, New Jersey, United States
Associates in Research, Inc.
🇺🇸Fresno, California, United States
Cherry Creek Dermatology
🇺🇸Denver, Colorado, United States
Probity Medical Research
🇨🇦Windsor, Ontario, Canada
Radiant Research
🇺🇸Philadelphia, Pennsylvania, United States