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

Plaque Psoriasis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540618
• Other study ID #: MI-CP082
• 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
• 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

• Plaque Psoriasis
• Psoriasis

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