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.

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

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Other: Placebo; Drug: MEDI-507; Drug: MEDI-507; Drug: MEDI-507

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.

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2S 3B3
      • The Dermatology Centre
  • Newfoundland and Labrador
    • St. Johns, Newfoundland and Labrador, Canada, A1B 3E1
      • Newlab Clinical Research
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V8
      • Queen Elizabeth II Health Sciences Center
  • Ontario
    • Waterloo, Ontario, Canada, N2J 1B7
      • Probity Medical Research
    • Windsor, Ontario, Canada, N8X 3V6
      • Probity Medical Research
  • Quebec
    • Montreal, Quebec, Canada, H2K 4L5
      • Innovaderm Research Inc.
    • Montreal, Quebec, Canada, H3H 1V4
      • International Dermatology Research
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85040
      • Mds Pharma Services (Us) Inc.
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Bressinck-Parker-Dinehart-Sangster Dermatology, PA
  • California
    • Fresno, California, United States, 93710
      • Associates In Research, Inc.
    • San Diego, California, United States, 92103
      • nTouch Research Corporation
    • Vallejo, California, United States, 94589
      • Solano Clinical Research
    • Vista, California, United States, 92083
      • Dermatology Specialists, Inc.
  • Colorado
    • Denver, Colorado, United States, 80210
      • Colorado Medical Research Center, Inc.
    • Denver, Colorado, United States, 80246
      • Cherry Creek Dermatology
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • The Savin Center, PC
  • Florida
    • Jacksonville, Florida, United States, 32204
      • North Florida Dermatology Associates, PA
    • Sarasota, Florida, United States, 34232
      • ICSL-Clinical Studies
    • Tampa, Florida, United States, 33607
      • Comprehensive Research Institute
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Atlanta Dermatology, Vein & Research Center, LLC
  • Illinois
    • Chicago, Illinois, United States, 60611-2923
      • Northwestern University Medical School
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Research Solutions, LLC
    • South Bend, Indiana, United States, 46617
      • The South Bend Clinic
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Springfield, Massachusetts, United States, 01107
      • FutureCare Studies
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Jersey
    • Delran, New Jersey, United States, 08075
      • Probe Inc.
    • New Brunswick, New Jersey, United States, 08903-0019
      • University of Medicine & Dentistry of New Jersey Robert Wood Johnson Medical School and Clinical Research Center
    • Rutherford, New Jersey, United States, 07070
      • Associates In Dermatology Research
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
    • New York, New York, United States, 10021
      • Sadick Research Group
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University School of Medicine
  • Ohio
    • Cincinnatti, Ohio, United States, 45219
      • University Dermatology Consultants, Inc.
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center, Pc
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Northeast Clinical Research Center
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Company
    • Philadelphia, Pennsylvania, United States, 19115
      • Radiant Research
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinicalm Partners-LLC
  • Tennessee
    • Johnson City, Tennessee, United States, 37601
      • Harmony Clinical Research, Inc.
    • Nashville, Tennessee, United States, 37205
      • Dermatology Consultants, PC
    • Nashville, Tennessee, United States, 37212-2637
      • Veteran's Administration Medical Center
  • Texas
    • Houston, Texas, United States, 77024
      • Breco Research, Ltd.
    • San Antonio, Texas, United States, 78229
      • Dermatology Clinical Research Center of San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2	Other: Placebo
Active Comparator: 1; MEDI-507	Drug: MEDI-507; Compare in a placebo controlled manner, the disease activity of three dosing regimens of MEDI-507 (Monoclonal Antibody); Drug: MEDI-507; Monoclonal Antibody (5 mg for 12 weeks and 5 mg for 6 weeks); Drug: MEDI-507; Administered 7 mg for 4 weeks by injection (Monoclonal Antibody)
Active Comparator: 3; MEDI-507	Drug: MEDI-507; Compare in a placebo controlled manner, the disease activity of three dosing regimens of MEDI-507 (Monoclonal Antibody); Drug: MEDI-507; Monoclonal Antibody (5 mg for 12 weeks and 5 mg for 6 weeks); Drug: MEDI-507; Administered 7 mg for 4 weeks by injection (Monoclonal Antibody)
Active Comparator: 4; MEDI-507	Drug: MEDI-507; Compare in a placebo controlled manner, the disease activity of three dosing regimens of MEDI-507 (Monoclonal Antibody); Drug: MEDI-507; Monoclonal Antibody (5 mg for 12 weeks and 5 mg for 6 weeks); Drug: MEDI-507; Administered 7 mg for 4 weeks by injection (Monoclonal Antibody)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Observe adverse and serious adverse events	Day 107 and 167

Collaborators and Investigators

• Sponsor: MedImmune LLC
• Investigators: Study Director: Christine A Dingivan, M.D., MedImmune LLC

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Study Completion (Actual): July 1, 2003

Study Registration Dates

• First Submitted: October 4, 2007
• First Submitted That Met QC Criteria: October 4, 2007
• First Posted (Estimate): October 8, 2007

Study Record Updates

• Last Update Posted (Estimate): November 28, 2007
• Last Update Submitted That Met QC Criteria: November 27, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: MI-CP082