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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00540618
Recruitment Status : Completed
First Posted : October 8, 2007
Last Update Posted : November 28, 2007
Information provided by:
MedImmune LLC

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

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: MEDI-507 Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : September 2001
Actual Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Active Comparator: 1
Drug: MEDI-507
Compare in a placebo controlled manner, the disease activity of three dosing regimens of MEDI-507 (Monoclonal Antibody)

Placebo Comparator: 2 Other: Placebo
Active Comparator: 3
Drug: MEDI-507
Monoclonal Antibody (5 mg for 12 weeks and 5 mg for 6 weeks)

Active Comparator: 4
Drug: MEDI-507
Administered 7 mg for 4 weeks by injection (Monoclonal Antibody)

Primary Outcome Measures :
  1. Biological activity will be assessed primarily by the Psoriasis Activity and Severity Index (PASI) [ Time Frame: Days 14, 28, 42, 56, 70, 91, 107, and 167 ]

Secondary Outcome Measures :
  1. Observe adverse and serious adverse events [ Time Frame: Day 107 and 167 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00540618

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Sponsors and Collaborators
MedImmune LLC
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Study Director: Christine A Dingivan, M.D. MedImmune LLC
Layout table for additonal information Identifier: NCT00540618    
Other Study ID Numbers: MI-CP082
First Posted: October 8, 2007    Key Record Dates
Last Update Posted: November 28, 2007
Last Verified: November 2007
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases