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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: MEDI-522; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • North Bay, Ontario, Canada, P1B 2T6
      • North Bay Dermatology Center
    • Waterloo, Ontario, Canada, N2J 1C4
      • Probity Medical Research, Inc.
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Bressinck, Gibson, Parker, Dinehart, Sanster Dermatology, PA
  • California
    • Fresno, California, United States, 93710
      • Associates In Research, Inc.
    • Vallejo, California, United States, 94589
      • Solano Dermatology Associates
    • Vista, California, United States, 92083
      • Dermatology Specialists
  • Connecticut
    • New Haven, Connecticut, United States, 06511-4808
      • The Savin Center, P.C.
  • Florida
    • Jacksonville, Florida, United States, 32204
      • North Florida Dermatology Associates, P.A.
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Atlanta Dermatology, Vein & Research Center, LLC
  • Indiana
    • South Bend, Indiana, United States, 46617
      • South Bend Clinic
  • Massachusetts
    • Springfield, Massachusetts, United States, 01107
      • FutureCare Studies, INC
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Midwest Cutaneous Research, Corp.
  • Missouri
    • St. Louis, Missouri, United States, 63117
      • Central Dermatology
  • New Jersey
    • Delran, New Jersey, United States, 08075
      • Karen Harkaway, M.D., LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • NorthEast Clinical Research Centers, Inc
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clincial Partners, LLC
  • Tennessee
    • Johnson City, Tennessee, United States, 37601
      • Harmony Clinical Research
    • Nashville, Tennessee, United States, 37215
      • Tenn. Clinical Research Center, INC
  • Texas
    • San Antonio, Texas, United States, 78229
      • Derm. Clinical Research Center of San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Other: Placebo; 4 mg/kg(for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)
Active Comparator: 1; MEDI-522	Drug: MEDI-522; 4 mg/kg (for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events and serious adverse events	through Study Day 167

Collaborators and Investigators

• Sponsor: MedImmune LLC
• Investigators: Study Director: Barbara White, M.D., MedImmune LLC

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Primary Completion (Actual): August 1, 2004
• Study Completion (Actual): September 1, 2004

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Estimate): April 3, 2009
• Last Update Submitted That Met QC Criteria: April 2, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: MI-CP102