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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00192517
• Other study ID #: MI-CP102
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: April 2, 2009
• Start date: December 2003
• Est. completion date: September 2004

Study information

• Verified date: April 2009
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• MEDI-522
4 mg/kg (for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)

Other:
• Placebo
4 mg/kg(for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)

Locations

Country	Name	City	State
Canada	North Bay Dermatology Center	North Bay	Ontario
Canada	Probity Medical Research, Inc.	Waterloo	Ontario
United States	NorthEast Clinical Research Centers, Inc	Allentown	Pennsylvania
United States	Atlanta Dermatology, Vein & Research Center, LLC	Alpharetta	Georgia
United States	University of Cincinnati	Cincinnati	Ohio
United States	Midwest Cutaneous Research, Corp.	Clinton Township	Michigan
United States	Karen Harkaway, M.D., LLC	Delran	New Jersey
United States	Associates In Research, Inc.	Fresno	California
United States	North Florida Dermatology Associates, P.A.	Jacksonville	Florida
United States	Harmony Clinical Research	Johnson City	Tennessee
United States	Clincial Partners, LLC	Johnston	Rhode Island
United States	Bressinck, Gibson, Parker, Dinehart, Sanster Dermatology, PA	Little Rock	Arkansas
United States	Tenn. Clinical Research Center, INC	Nashville	Tennessee
United States	The Savin Center, P.C.	New Haven	Connecticut
United States	Derm. Clinical Research Center of San Antonio	San Antonio	Texas
United States	South Bend Clinic	South Bend	Indiana
United States	FutureCare Studies, INC	Springfield	Massachusetts
United States	Central Dermatology	St. Louis	Missouri
United States	Solano Dermatology Associates	Vallejo	California
United States	Dermatology Specialists	Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Incidence of adverse events and serious adverse events		through Study Day 167	Yes