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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MEDI-522
Placebo
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bressinck, Gibson, Parker, Dinehart, Sanster Dermatology, PA
  • Associates In Research, Inc.
  • Solano Dermatology Associates
  • Dermatology Specialists
  • The Savin Center, P.C.
  • North Florida Dermatology Associates, P.A.
  • Atlanta Dermatology, Vein & Research Center, LLC
  • South Bend Clinic
  • FutureCare Studies, INC
  • Midwest Cutaneous Research, Corp.
  • Central Dermatology
  • Karen Harkaway, M.D., LLC
  • University of Cincinnati
  • NorthEast Clinical Research Centers, Inc
  • Clincial Partners, LLC
  • Harmony Clinical Research
  • Tenn. Clinical Research Center, INC
  • Derm. Clinical Research Center of San Antonio
  • North Bay Dermatology Center
  • Probity Medical Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

MEDI-522

Placebo

Outcomes

Primary Outcome Measures

Percentage of subjects achieving at least a 50% or 75% improvement of PASI

Secondary Outcome Measures

Incidence of adverse events and serious adverse events

Full Information

First Posted
September 13, 2005
Last Updated
April 2, 2009
Sponsor
MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00192517
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MedImmune LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
MEDI-522
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
MEDI-522
Intervention Description
4 mg/kg (for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
4 mg/kg(for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Incidence of adverse events and serious adverse events
Time Frame
through Study Day 167

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara White, M.D.
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
Bressinck, Gibson, Parker, Dinehart, Sanster Dermatology, PA
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Associates In Research, Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Solano Dermatology Associates
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Dermatology Specialists
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
The Savin Center, P.C.
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511-4808
Country
United States
Facility Name
North Florida Dermatology Associates, P.A.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Atlanta Dermatology, Vein & Research Center, LLC
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
FutureCare Studies, INC
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Midwest Cutaneous Research, Corp.
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Central Dermatology
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Karen Harkaway, M.D., LLC
City
Delran
State/Province
New Jersey
ZIP/Postal Code
08075
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
NorthEast Clinical Research Centers, Inc
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Clincial Partners, LLC
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Harmony Clinical Research
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
Tenn. Clinical Research Center, INC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Derm. Clinical Research Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
North Bay Dermatology Center
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 2T6
Country
Canada
Facility Name
Probity Medical Research, Inc.
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada

12. IPD Sharing Statement

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

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