Clinical trial NCT00540618: A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2007-10-08
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Biological activity will be assessed primarily by the Psoriasis Activity and Severity Index (PASI)
timeFrame: Days 14, 28, 42, 56, 70, 91, 107, and 167
Secondary outcomes:
measure: Observe adverse and serious adverse events
timeFrame: Day 107 and 167
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: MDS Pharma Services (US) Inc.
state: Arizona
city: Little Rock
country: United States
facility: Bressinck-Parker-Dinehart-Sangster Dermatology, PA
state: Arkansas
city: Fresno
country: United States
facility: Associates in Research, Inc.
state: California
city: San Diego
country: United States
facility: nTouch Research Corporation
state: California
city: Vallejo
country: United States
facility: Solano Clinical Research
state: California
city: Vista
country: United States
facility: Dermatology Specialists, Inc.
state: California
city: Denver
country: United States
facility: Colorado Medical Research Center, Inc.
state: Colorado
city: Denver
country: United States
facility: Cherry Creek Dermatology
state: Colorado
city: New Haven
country: United States
facility: The Savin Center, PC
state: Connecticut
city: Jacksonville
country: United States
facility: North Florida Dermatology Associates, PA
state: Florida
city: Sarasota
country: United States
facility: ICSL-Clinical Studies
state: Florida
city: Tampa
country: United States
facility: Comprehensive Research Institute
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein & Research Center, LLC
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Medical School
state: Illinois
city: Evansville
country: United States
facility: Research Solutions, LLC
state: Indiana
city: South Bend
country: United States
facility: The South Bend Clinic
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Springfield
country: United States
facility: FutureCare Studies
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Delran
country: United States
facility: Probe Inc.
state: New Jersey
city: New Brunswick
country: United States
facility: University of Medicine & Dentistry of New Jersey Robert Wood Johnson Medical School and Clinical Research Center
state: New Jersey
city: Rutherford
country: United States
facility: Associates in Dermatology Research
state: New Jersey
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cincinnatti
country: United States
facility: University Dermatology Consultants, Inc.
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center, PC
state: Oregon
city: Allentown
country: United States
facility: Northeast Clinical Research Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Paddington Testing Company
state: Pennsylvania
city: Philadelphia
country: United States
facility: Radiant Research
state: Pennsylvania
city: Johnston
country: United States
facility: Clinicalm Partners-LLC
state: Rhode Island
city: Johnson City
country: United States
facility: Harmony Clinical Research, Inc.
state: Tennessee
city: Nashville
country: United States
facility: Dermatology Consultants, PC
state: Tennessee
city: Nashville
country: United States
facility: Veteran's Administration Medical Center
state: Tennessee
city: Houston
country: United States
facility: Breco Research, Ltd.
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Calgary
country: Canada
facility: The Dermatology Centre
state: Alberta
city: St. Johns
country: Canada
facility: NewLab Clinical Research
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Center
state: Nova Scotia
city: Waterloo
country: Canada
facility: Probity Medical Research
state: Ontario
city: Windsor
country: Canada
facility: Probity Medical Research
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Montreal
country: Canada
facility: International Dermatology Research
state: Quebec
Study officials:
affiliation: MedImmune LLC
name: Christine A Dingivan, M.D.
role: STUDY_DIRECTOR
References: