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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00540618
Other study ID # MI-CP082
Secondary ID
Status Completed
Phase Phase 2
First received October 4, 2007
Last updated November 27, 2007
Start date September 2001
Est. completion date July 2003

Study information

Verified date November 2007
Source MedImmune LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To compare disease activity, as measured by PASI score, of three MEDI-507 dosing (injection)regimens vs. placebo.


Description:

The primary objective of this study is to compare disease activity, as measured by PASI score, of three MEDI-507 dosing regimens (5 mg for 12 weeks, 5 mg for 6 weeks, 7 mg for 4 weeks) versus placebo administered weekly by SC injection.


Recruitment information / eligibility

Status Completed
Enrollment 420
Est. completion date July 2003
Est. primary completion date
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

- 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

- Currently receiving no therapy for psoriasis except emollients (certain other over-the-counter products may be allowed with prior approval of the sponsor)

- 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

- PASI score <8

- At screening (must be within 21 days before study entry) any of the following: lymphocyte count under 1,200 cells/mm3, WBC under 4,000 cells/mm3, hematocrit below 32%, platelets below 110,000 cells/mm3, creatinine, AST, ALT over 1.5 times upper limit of normal

- At screening (must be within 21 days before study entry) any clinical evidence of HIV, hepatitis B, hepatitis C or active hepatitis A infection

- 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)

- Any documented immunodeficiency

- A history of prior administration of monoclonal antibodies or related proteins

- Receipt of systemic retinoids, corticosteroids, cyclosporin A, methotrexate, phototherapy or coal tar treatment in the past 4 weeks

- Use of topical therapy (except emollients) for psoriasis in the past 2 weeks (certain other over-the-counter products may be allowed with prior approval of the sponsor)

- Receipt of any investigational drug therapy within 6 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

- Nursing mother

- Acute illness including infections 15. Clinical manifestations of significant end organ dysfunction or failure that may compromise the safety of the volunteer in the study

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
MEDI-507
Compare in a placebo controlled manner, the disease activity of three dosing regimens of MEDI-507 (Monoclonal Antibody)
Other:
Placebo

Drug:
MEDI-507
Monoclonal Antibody (5 mg for 12 weeks and 5 mg for 6 weeks)
MEDI-507
Administered 7 mg for 4 weeks by injection (Monoclonal Antibody)

Locations

Country Name City State
Canada The Dermatology Centre Calgary Alberta
Canada Queen Elizabeth II Health Sciences Center Halifax Nova Scotia
Canada Innovaderm Research Inc. Montreal Quebec
Canada International Dermatology Research Montreal Quebec
Canada NewLab Clinical Research St. Johns Newfoundland and Labrador
Canada Probity Medical Research Waterloo Ontario
Canada Probity Medical Research Windsor Ontario
United States Northeast Clinical Research Center Allentown Pennsylvania
United States Atlanta Dermatology, Vein & Research Center, LLC Alpharetta Georgia
United States Massachusetts General Hospital Boston Massachusetts
United States Northwestern University Medical School Chicago Illinois
United States University Dermatology Consultants, Inc. Cincinnatti Ohio
United States Probe Inc. Delran New Jersey
United States Cherry Creek Dermatology Denver Colorado
United States Colorado Medical Research Center, Inc. Denver Colorado
United States Research Solutions, LLC Evansville Indiana
United States Associates in Research, Inc. Fresno California
United States Breco Research, Ltd. Houston Texas
United States North Florida Dermatology Associates, PA Jacksonville Florida
United States Harmony Clinical Research, Inc. Johnson City Tennessee
United States Clinicalm Partners-LLC Johnston Rhode Island
United States Bressinck-Parker-Dinehart-Sangster Dermatology, PA Little Rock Arkansas
United States Dermatology Consultants, PC Nashville Tennessee
United States Veteran's Administration Medical Center Nashville Tennessee
United States University of Medicine & Dentistry of New Jersey Robert Wood Johnson Medical School and Clinical Research Center New Brunswick New Jersey
United States The Savin Center, PC New Haven Connecticut
United States Mount Sinai School of Medicine New York New York
United States Sadick Research Group New York New York
United States Paddington Testing Company Philadelphia Pennsylvania
United States Radiant Research Philadelphia Pennsylvania
United States MDS Pharma Services (US) Inc. Phoenix Arizona
United States Oregon Medical Research Center, PC Portland Oregon
United States Associates in Dermatology Research Rutherford New Jersey
United States Dermatology Clinical Research Center of San Antonio San Antonio Texas
United States nTouch Research Corporation San Diego California
United States ICSL-Clinical Studies Sarasota Florida
United States The South Bend Clinic South Bend Indiana
United States FutureCare Studies Springfield Massachusetts
United States Washington University School of Medicine St. Louis Missouri
United States Comprehensive Research Institute Tampa Florida
United States Solano Clinical Research Vallejo California
United States Dermatology Specialists, Inc. Vista California
United States Wake Forest University School of Medicine Winston-Salem North Carolina

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 Biological activity will be assessed primarily by the Psoriasis Activity and Severity Index (PASI) Days 14, 28, 42, 56, 70, 91, 107, and 167
Secondary Observe adverse and serious adverse events Day 107 and 167
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