A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis

Completed · Phase 2 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

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

Key facts

Study ID

NCT00540618

Run by

MedImmune LLC

People needed

420

Starts

2001-09-01

Expected to finish

2003-07-01

Last updated by the study team

2007-11-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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