Study of MEDI-522 Administered by Subcutaneous Injection to Adults With Plaque Psoriasis
- Registration Number
- NCT00192517
- Lead Sponsor
- MedImmune LLC
- Brief Summary
The primary objective of this study is to compare the effects on disease activity, in the absence of systemic psoriasis therapy, of 4 mg/kg MEDI-522 versus placebo administered weekly by SC injection for 12 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- Plaque psoriasis involving at least 10% of body surface area (Appendix A)
- PASI score greater than 12
- 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 using such precautions for 60 days after the final dose of study drug
- Prior to randomization (must be within 21 days of the first administration of the study drug), all of the following: WBC less than or equal to 3,800/mm3; hematocrit above 32%, platelet count less than or equal to 140,000/mm3; AST, ALT, BUN, or creatinine<1.5 x ULN; and stool negative for occult blood
- Currently receiving no therapy for psoriasis except emollients
- 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
- Evidence of active hepatitis A, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, such as positive HBsAg or positive anti-hepatitis C antibody
- 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)
- Evidence of significant active infection, such as fever less than or greater to 38.0ยฐC (100.5ยฐF), or chronic systemic infection
- Known or suspected infection with human immunodeficiency virus (HIV) or other evidence of clinically significant immune deficiencies
- Diagnosis of psoriatic arthritis or rheumatoid arthritis requiring active treatment
- History of hematuria due to chronic cystitis, recurrent kidney stones, or nephritis, history of CVA, poorly controlled hypertension, angina, stable abdominal aneurysm, recent superficial phlebitis, or recent myocardial infarction (within past 1 year without definitive corrective surgery such as coronary bypass graft or angioplasty)
- Receipt of systemic therapy for psoriasis or immunosuppressive medication in the past 4 weeks, including systemic retinoids, systemic steroids (oral, IM, or IV), cyclosporine A,methotrexate, azathioprine, anti-TNF agents, anti-T-cell agents, phototherapy (PUVA, UVB,tanning bed use), coal tar treatment (Goeckerman or modified Goeckerman regimen), tacrolimus, or mycophenolate
- Use of topical therapy for psoriasis in the past 2 weeks, such as steroid containing creams, Vitamin D analog creams and coal tar shampoos
- Receipt of any investigational drug therapy within 4 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
- History of allergic disease or reactions likely to be exacerbated by any component of MEDI-522
- Nursing mother
- Evidence of acute illness
- Clinical manifestations of significant end organ dysfunction or failure that may compromise the safety of the patient in the study
- History of gastrointestinal bleeding (i.e., stool positive for occult blood or overt bleeding) within the previous 6 months
- Known bleeding disorder or significant risk of clinically important abnormal bleeding due to anticoagulant therapy with warfarin or heparin
- Insulin-dependent diabetes mellitus that is recent-onset or unstable
- Elective surgery planned during the study period through Study Day 167
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 MEDI-522 MEDI-522 2 Placebo Placebo
- Primary Outcome Measures
Name Time Method Percentage of subjects achieving at least a 50% or 75% improvement of PASI PASI score at Study Days 28, 56, 77, 91, 107, 137, and 167.
- Secondary Outcome Measures
Name Time Method Incidence of adverse events and serious adverse events through Study Day 167
Trial Locations
- Locations (20)
NorthEast Clinical Research Centers, Inc
๐บ๐ธAllentown, Pennsylvania, United States
South Bend Clinic
๐บ๐ธSouth Bend, Indiana, United States
Dermatology Specialists
๐บ๐ธVista, California, United States
North Bay Dermatology Center
๐จ๐ฆNorth Bay, Ontario, Canada
Solano Dermatology Associates
๐บ๐ธVallejo, California, United States
Associates In Research, Inc.
๐บ๐ธFresno, California, United States
Probity Medical Research, Inc.
๐จ๐ฆWaterloo, Ontario, Canada
Midwest Cutaneous Research, Corp.
๐บ๐ธClinton Township, Michigan, United States
Atlanta Dermatology, Vein & Research Center, LLC
๐บ๐ธAlpharetta, Georgia, United States
Central Dermatology
๐บ๐ธSt. Louis, Missouri, United States
FutureCare Studies, INC
๐บ๐ธSpringfield, Massachusetts, United States
Tenn. Clinical Research Center, INC
๐บ๐ธNashville, Tennessee, United States
Derm. Clinical Research Center of San Antonio
๐บ๐ธSan Antonio, Texas, United States
Clincial Partners, LLC
๐บ๐ธJohnston, Rhode Island, United States
The Savin Center, P.C.
๐บ๐ธNew Haven, Connecticut, United States
University of Cincinnati
๐บ๐ธCincinnati, Ohio, United States
Karen Harkaway, M.D., LLC
๐บ๐ธDelran, New Jersey, United States
Harmony Clinical Research
๐บ๐ธJohnson City, Tennessee, United States
North Florida Dermatology Associates, P.A.
๐บ๐ธJacksonville, Florida, United States
Bressinck, Gibson, Parker, Dinehart, Sanster Dermatology, PA
๐บ๐ธLittle Rock, Arkansas, United States