A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis

Study Overview
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Brief Summary
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To compare disease activity, as measured by PASI score, of three MEDI-507 dosing (injection)regimens vs. placebo.

Detailed Description
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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.

Official Title
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A Phase II Randomized, Placebo-Controlled, Double-Blind Study of MEDI-507, A Humanized Monoclonal Antibody That Binds to the CD2 Receptor, Administered by Subcutaneous Injection to Adults With Plaque Psoriasis.

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: MEDI-507
* Other: Placebo
* Drug: MEDI-507
* Drug: MEDI-507


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>MEDI-507 | Drug: MEDI-507<br>* Compare in a placebo controlled manner, the disease activity of three dosing regimens of MEDI-507 (Monoclonal Antibody)<br>|
| Placebo Comparator: 2<br> | Other: Placebo<br> <br> |
| Active Comparator: 3<br>MEDI-507 | Drug: MEDI-507<br>* Monoclonal Antibody (5 mg for 12 weeks and 5 mg for 6 weeks)<br>|
| Active Comparator: 4<br>MEDI-507 | Drug: MEDI-507<br>* Administered 7 mg for 4 weeks by injection (Monoclonal Antibody)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observe adverse and serious adverse events |  | Day 107 and 167 |