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

• ClinicalTrials.gov Identifier: NCT00192517
• Recruitment Status: Completed
• First Posted: September 19, 2005
• Last Update Posted: April 3, 2009
• Sponsor: MedImmune LLC
• Information provided by: MedImmune LLC

Tracking Information

• First Submitted Date: September 13, 2005
• First Posted Date: September 19, 2005
• Last Update Posted Date: April 3, 2009
• Study Start Date: December 2003
• Actual Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 2, 2009): Percentage of subjects achieving at least a 50% or 75% improvement of PASI [ Time Frame: PASI score at Study Days 28, 56, 77, 91, 107, 137, and 167. ]
• Original Primary Outcome Measures (submitted: September 13, 2005): - Percentage of subjects achieving at least a 50% or 75% improvement of PASI
• Current Secondary Outcome Measures (submitted: April 2, 2009): Incidence of adverse events and serious adverse events [ Time Frame: through Study Day 167 ]

Original Secondary Outcome Measures (submitted: September 13, 2005)

• - Incidence of adverse events and serious adverse events through Study Day 167
• - Changes from baseline in CBC with differential, serum chemistry and vital signes
• - Mean serum concentrations of MEDI-522
• - Numbers and percentages of patients with and without detectable anti-MEDI-522 antibodies

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: 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)

Study Arms

• Active Comparator: 1
  MEDI-522
  Intervention: Drug: MEDI-522
• Placebo Comparator: 2
  Placebo
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 2, 2009): 44
• Original Enrollment (submitted: September 13, 2005): 60
• Actual Study Completion Date: September 2004
• Actual Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT00192517
• Other Study ID Numbers: MI-CP102
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Barbara White, M.D., MedImmune Inc.
• Study Sponsor: MedImmune LLC
• Collaborators: Not Provided

Investigators

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

• PRS Account: MedImmune LLC
• Verification Date: April 2009