A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis
NCT ID: NCT00540618
Last Updated: 2007-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
420 participants
INTERVENTIONAL
2001-09-30
2003-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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1
MEDI-507
MEDI-507
Compare in a placebo controlled manner, the disease activity of three dosing regimens of MEDI-507 (Monoclonal Antibody)
2
Placebo
3
MEDI-507
MEDI-507
Monoclonal Antibody (5 mg for 12 weeks and 5 mg for 6 weeks)
4
MEDI-507
MEDI-507
Administered 7 mg for 4 weeks by injection (Monoclonal Antibody)
Interventions
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MEDI-507
Compare in a placebo controlled manner, the disease activity of three dosing regimens of MEDI-507 (Monoclonal Antibody)
Placebo
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Principal Investigators
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Christine A Dingivan, M.D.
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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MDS Pharma Services (US) Inc.
Phoenix, Arizona, United States
Bressinck-Parker-Dinehart-Sangster Dermatology, PA
Little Rock, Arkansas, United States
Associates in Research, Inc.
Fresno, California, United States
nTouch Research Corporation
San Diego, California, United States
Solano Clinical Research
Vallejo, California, United States
Dermatology Specialists, Inc.
Vista, California, United States
Colorado Medical Research Center, Inc.
Denver, Colorado, United States
Cherry Creek Dermatology
Denver, Colorado, United States
The Savin Center, PC
New Haven, Connecticut, United States
North Florida Dermatology Associates, PA
Jacksonville, Florida, United States
ICSL-Clinical Studies
Sarasota, Florida, United States
Comprehensive Research Institute
Tampa, Florida, United States
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, United States
Northwestern University Medical School
Chicago, Illinois, United States
Research Solutions, LLC
Evansville, Indiana, United States
The South Bend Clinic
South Bend, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
FutureCare Studies
Springfield, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Medicine & Dentistry of New Jersey Robert Wood Johnson Medical School and Clinical Research Center
New Brunswick, New Jersey, United States
Probe Inc.
Riverside Park, New Jersey, United States
Associates in Dermatology Research
Rutherford, New Jersey, United States
Sadick Research Group
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
University Dermatology Consultants, Inc.
Cincinnatti, Ohio, United States
Oregon Medical Research Center, PC
Portland, Oregon, United States
Northeast Clinical Research Center
Allentown, Pennsylvania, United States
Paddington Testing Company
Philadelphia, Pennsylvania, United States
Radiant Research
Philadelphia, Pennsylvania, United States
Clinicalm Partners-LLC
Johnston, Rhode Island, United States
Harmony Clinical Research, Inc.
Johnson City, Tennessee, United States
Dermatology Consultants, PC
Nashville, Tennessee, United States
Veteran's Administration Medical Center
Nashville, Tennessee, United States
Breco Research, Ltd.
Houston, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
The Dermatology Centre
Calgary, Alberta, Canada
NewLab Clinical Research
St. John's, Newfoundland and Labrador, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada
Probity Medical Research
Waterloo, Ontario, Canada
Probity Medical Research
Windsor, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
International Dermatology Research
Montreal, Quebec, Canada
Countries
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Other Identifiers
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MI-CP082
Identifier Type: -
Identifier Source: org_study_id