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

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192452
First received: September 13, 2005
Last updated: October 23, 2006
Last verified: October 2006
  Purpose

- 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.


Condition Intervention Phase
Psoriasis
Drug: MEDI-507
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

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.

Estimated Enrollment: 120
Study Start Date: March 2001
Estimated Study Completion Date: December 2001
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192452

Locations
United States, Arizona
MDS Pharma Services (US) Inc.
Phoenix, Arizona, United States, 85044
United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Washington
Northwest Kinetics
Tacoma, Washington, United States, 98403
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Stanley Pillemer, MD MedImmune LLC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00192452     History of Changes
Other Study ID Numbers: MI-CP074
Study First Received: September 13, 2005
Last Updated: October 23, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on October 23, 2014