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

April 2, 2009 updated by: MedImmune LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
PASI score at Study Days 28, 56, 77, 91, 107, 137, and 167.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of adverse events and serious adverse events
Time Frame: through Study Day 167
through Study Day 167

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MedImmune LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Barbara White, M.D., MedImmune LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MI-CP102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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