A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis
A Phase II Randomized, Placebo-Controlled, Double-Blind Study of MEDI-507, A Humanized Monoclonal Antibody That Binds to the CD2 Receptor, Administered by Subcutaneous Injection to Adults With Plaque Psoriasis.
1 other identifier
interventional
420
2 countries
43
Brief Summary
To compare disease activity, as measured by PASI score, of three MEDI-507 dosing (injection)regimens vs. placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2001
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 4, 2007
CompletedFirst Posted
Study publicly available on registry
October 8, 2007
CompletedNovember 28, 2007
November 1, 2007
October 4, 2007
November 27, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Observe adverse and serious adverse events
Day 107 and 167
Study Arms (4)
1
ACTIVE COMPARATORMEDI-507
2
PLACEBO COMPARATOR3
ACTIVE COMPARATORMEDI-507
4
ACTIVE COMPARATORMEDI-507
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (43)
MDS Pharma Services (US) Inc.
Phoenix, Arizona, 85040, United States
Bressinck-Parker-Dinehart-Sangster Dermatology, PA
Little Rock, Arkansas, 72205, United States
Associates in Research, Inc.
Fresno, California, 93710, United States
nTouch Research Corporation
San Diego, California, 92103, United States
Solano Clinical Research
Vallejo, California, 94589, United States
Dermatology Specialists, Inc.
Vista, California, 92083, United States
Colorado Medical Research Center, Inc.
Denver, Colorado, 80210, United States
Cherry Creek Dermatology
Denver, Colorado, 80246, United States
The Savin Center, PC
New Haven, Connecticut, 06511, United States
North Florida Dermatology Associates, PA
Jacksonville, Florida, 32204, United States
ICSL-Clinical Studies
Sarasota, Florida, 34232, United States
Comprehensive Research Institute
Tampa, Florida, 33607, United States
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, 30005, United States
Northwestern University Medical School
Chicago, Illinois, 60611-2923, United States
Research Solutions, LLC
Evansville, Indiana, 47714, United States
The South Bend Clinic
South Bend, Indiana, 46617, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
FutureCare Studies
Springfield, Massachusetts, 01107, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Medicine & Dentistry of New Jersey Robert Wood Johnson Medical School and Clinical Research Center
New Brunswick, New Jersey, 08903-0019, United States
Probe Inc.
Riverside Park, New Jersey, 08075, United States
Associates in Dermatology Research
Rutherford, New Jersey, 07070, United States
Sadick Research Group
New York, New York, 10021, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
University Dermatology Consultants, Inc.
Cincinnatti, Ohio, 45219, United States
Oregon Medical Research Center, PC
Portland, Oregon, 97223, United States
Northeast Clinical Research Center
Allentown, Pennsylvania, 18104, United States
Paddington Testing Company
Philadelphia, Pennsylvania, 19103, United States
Radiant Research
Philadelphia, Pennsylvania, 19115, United States
Clinicalm Partners-LLC
Johnston, Rhode Island, 02919, United States
Harmony Clinical Research, Inc.
Johnson City, Tennessee, 37601, United States
Dermatology Consultants, PC
Nashville, Tennessee, 37205, United States
Veteran's Administration Medical Center
Nashville, Tennessee, 37212-2637, United States
Breco Research, Ltd.
Houston, Texas, 77024, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229, United States
The Dermatology Centre
Calgary, Alberta, T2S 3B3, Canada
NewLab Clinical Research
St. John's, Newfoundland and Labrador, A1B 3E1, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 1V8, Canada
Probity Medical Research
Waterloo, Ontario, N2J 1B7, Canada
Probity Medical Research
Windsor, Ontario, N8X 3V6, Canada
Innovaderm Research Inc.
Montreal, Quebec, H2K 4L5, Canada
International Dermatology Research
Montreal, Quebec, H3H 1V4, Canada
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Christine A Dingivan, M.D.
MedImmune LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 4, 2007
First Posted
October 8, 2007
Study Start
September 1, 2001
Study Completion
July 1, 2003
Last Updated
November 28, 2007
Record last verified: 2007-11