Clinical trial NCT00192517: Study of MEDI-522 Administered by Subcutaneous Injection to Adults With Plaque Psoriasis
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of MEDI-522, a Humanized Monoclonal Antibody to Integrin Alpha V Beta 3, Administered by Subcutaneous Injection to Adults With Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of subjects achieving at least a 50% or 75% improvement of PASI
timeFrame: PASI score at Study Days 28, 56, 77, 91, 107, 137, and 167.
Secondary outcomes:
measure: Incidence of adverse events and serious adverse events
timeFrame: through Study Day 167
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Bressinck, Gibson, Parker, Dinehart, Sanster Dermatology, PA
state: Arkansas
city: Fresno
country: United States
facility: Associates In Research, Inc.
state: California
city: Vallejo
country: United States
facility: Solano Dermatology Associates
state: California
city: Vista
country: United States
facility: Dermatology Specialists
state: California
city: New Haven
country: United States
facility: The Savin Center, P.C.
state: Connecticut
city: Jacksonville
country: United States
facility: North Florida Dermatology Associates, P.A.
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein & Research Center, LLC
state: Georgia
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: Springfield
country: United States
facility: FutureCare Studies, INC
state: Massachusetts
city: Clinton Township
country: United States
facility: Midwest Cutaneous Research, Corp.
state: Michigan
city: St. Louis
country: United States
facility: Central Dermatology
state: Missouri
city: Delran
country: United States
facility: Karen Harkaway, M.D., LLC
state: New Jersey
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Allentown
country: United States
facility: NorthEast Clinical Research Centers, Inc
state: Pennsylvania
city: Johnston
country: United States
facility: Clincial Partners, LLC
state: Rhode Island
city: Johnson City
country: United States
facility: Harmony Clinical Research
state: Tennessee
city: Nashville
country: United States
facility: Tenn. Clinical Research Center, INC
state: Tennessee
city: San Antonio
country: United States
facility: Derm. Clinical Research Center of San Antonio
state: Texas
city: North Bay
country: Canada
facility: North Bay Dermatology Center
state: Ontario
city: Waterloo
country: Canada
facility: Probity Medical Research, Inc.
state: Ontario
Study officials:
affiliation: MedImmune LLC
name: Barbara White, M.D.
role: STUDY_DIRECTOR
References: