Study of MEDI-522 Administered by Subcutaneous Injection to Adults With Plaque Psoriasis

MedImmune

Status and phase

Completed

Phase 2

Conditions

Psoriasis

Treatments

Drug: MEDI-522

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00192517

MI-CP102

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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 38.0°C (100.5°F), 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