Plaque Psoriasis
Conditions
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.
Interventions
DRUGMEDI-507
Compare in a placebo controlled manner, the disease activity of three dosing regimens of MEDI-507 (Monoclonal Antibody)
OTHERPlacebo
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Observe adverse and serious adverse events | Day 107 and 167 |
Countries
Canada, United States
Outcome results
None listed