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Study of MEDI-507 Administered by Intravenous Infusion to Adults With Plaque Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MEDI-507
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Plaque psoriasis involving at least 10% of body surface area (Appendix B) 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 using such precautions for 60 days after the final dose of study drug 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 188 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, with the exception of MEDI-507 (Note: prior recipients of MEDI-507 will require review and approval by the sponsor prior to entry) 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 Clinical manifestations of significant end organ dysfunction or failure that may compromise the safety of the volunteer in the study A known drug allergy or medical contraindication to ibuprofen

Sites / Locations

  • MDS Pharma Services (US) Inc.
  • Wake Forest University School of Medicine
  • Northwest Kinetics

Outcomes

Primary Outcome Measures

Analyses of categorical data will be performed and analysis of continuous data will be performed using a one-way analysis of variance (ANOVA) with traetment group as a factor.

Secondary Outcome Measures

Percentage of subjects with at least 75% improvement and those with at least 50% improvement will be compared.

Full Information

First Posted
September 13, 2005
Last Updated
October 23, 2006
Sponsor
MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00192452
Brief Title
Study of MEDI-507 Administered by Intravenous Infusion to Adults With Plaque Psoriasis
Official Title
A Phase II Randomized, Double-Blind, Placebo-Controlled Study of MEDI-507, a Humanized Monoclonal Antibody That Binds to the CD2 Receptor, Administered by Intravenous Infusion to Adults With Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
MedImmune LLC

4. Oversight

5. Study Description

Brief Summary
- The primary objective of this study is to compare disease activity, as measured by PASI score, of two MEDI-507 dose levels (0.012 and 0.04 mg/kg) versus placebo administered by intravenous infusion every 2 weeks for a total of 8 infusions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
MEDI-507
Primary Outcome Measure Information:
Title
Analyses of categorical data will be performed and analysis of continuous data will be performed using a one-way analysis of variance (ANOVA) with traetment group as a factor.
Secondary Outcome Measure Information:
Title
Percentage of subjects with at least 75% improvement and those with at least 50% improvement will be compared.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Plaque psoriasis involving at least 10% of body surface area (Appendix B) 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 using such precautions for 60 days after the final dose of study drug 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 188 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, with the exception of MEDI-507 (Note: prior recipients of MEDI-507 will require review and approval by the sponsor prior to entry) 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 Clinical manifestations of significant end organ dysfunction or failure that may compromise the safety of the volunteer in the study A known drug allergy or medical contraindication to ibuprofen
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley Pillemer, MD
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
MDS Pharma Services (US) Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85044
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Northwest Kinetics
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98403
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of MEDI-507 Administered by Intravenous Infusion to Adults With Plaque Psoriasis

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