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Safety and Pharmacokinetics (PK) of Alefacept in Adolescent Subjects With Moderate to Severe 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: NCT00808223
Recruitment Status : Completed
First Posted : December 15, 2008
Last Update Posted : December 12, 2013
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
To establish the safety of alefacept when administered to adolescent subjects with moderate to severe psoriasis.

Condition or disease Intervention/treatment Phase
Psoriasis Biological: alefacept Phase 2

Detailed Description:
A planned interim analysis will be conducted to evaluate safety and pharmacokinetics following the Week 4 evaluation of approximately the first 12 subjects. A dose adjustment may be implemented based on these results. A preliminary review of the Week 4 pharmacokinetics of the first 6 subjects will occur to monitor exposure. If a dose adjustment is required, pharmacokinetics will be repeated for the first 12 subjects enrolled at the new dose (subjects 13-24).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Single-Arm Study to Evaluate the Safety and Pharmacokinetics of Alefacept in Adolescent Subjects With Moderate to Severe Psoriasis [ISN 0485-CL-0004]
Study Start Date : April 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: 1. alefacept Biological: alefacept
IM injection
Other Names:
  • Amevive
  • ASP0485

Primary Outcome Measures :
  1. Assessment of Physical exams, vital signs, select blood chemistry and hematology, lymphocyte subset analysis, anti-alefacept antibody monitoring, adverse event monitoring including infections. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Assessment of Pharmacodynamics: Total lymphocytes and lymphocyte subsets [ Time Frame: 4 Weeks ]
  2. Assessment of Pharmacokinetics through analysis of blood samples (only approximately first 24 subjects enrolled) [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject has moderate to severe chronic plaque psoriasis involving at least 10% or greater body surface area
  • Subject is a candidate for systemic treatment or phototherapy
  • Subject is in good health and alefacept is not contraindicated
  • Subject must have absolute total CD4+ lymphocyte counts within the normal range at screening
  • Female subjects of child bearing potential have a negative pregnancy test prior to first dose of alefacept and agree to practice effective contraception during the study
  • Subject must have predosing laboratory findings without clinically significant abnormal values for hematocrit, hemoglobin, platelets, white blood count and differential, serum creatinine, bilirubin, ALT, AST and prothrombin.
  • Subject must have completed all standard childhood immunizations at least 12 weeks prior to the first dose
  • Subject meets medication washout requirements and agrees to follow medication restrictions during the study
  • Subject agrees to comply with the study requirements and agrees to come to the clinic for required study visits

Exclusion Criteria:

  • Subject has a primary dermatological diagnosis of psoriasis other than plaque psoriasis
  • Subject has a known hypersensitivity to alefacept or any excipient of the study medication
  • Subject has had a serious local infection or systemic infection within 12 weeks prior to the first dose of study drug
  • Subject has a fever (body temperature ≥ 38°C [or > 37°C for sites in Latvia]) or symptomatic viral or bacterial infection (including upper respiratory tract infection) within 1 week prior to the first dose of study drug
  • Subject is known to be positive for HIV antibodies
  • Subject has a history of chronic serious infection including hepatic disease or has positive result to serology test for hepatitis A antibody IgM, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) antibody or, in Europe, tubercle bacillus (TB) at Screening
  • Subject has a history or evidence of tuberculosis based on serology or a positive PPD skin test at Screening
  • Subject has had treatment with any immunosuppressant agent within 12 weeks, any antibody or immuno-globulin within 24 weeks, or any investigational drug or approved therapy for investigational use within 8 weeks prior to the first dose of study drug
  • Subject has had more than six herpes simplex virus (HSV) breakouts per year or is currently having an outbreak or has had an outbreak within the last 24 weeks
  • Subject has a history of malignancy (other than non-melanoma skin cancers)
  • Subject has a chronic condition which is not well controlled
  • Subject is pregnant or nursing
  • Subject has a history of severe allergic or anaphylactic reactions

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): NCT00808223

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United States, California
Pediatric and Adolescent Dermatology
San Diego, California, United States, 92123
United States, Kentucky
Physicians Skin Care, PLLC
Louisville, Kentucky, United States, 40217
First Municipal Hospital for Active Treatment - Sofia
Sofia, Bulgaria, 1000
Skin and STD Clinical Centre
Riga, Latvia, 1001
Department of Dermatology No.17, Children Clinical Hospital
Riga, Latvia, 1004
Sponsors and Collaborators
Astellas Pharma Inc
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Study Director: Vice President Medical Affairs Astellas Pharma Global Development

Additional Information:
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Responsible Party: Astellas Pharma Inc Identifier: NCT00808223    
Other Study ID Numbers: 0485-CL-0004
2008-005830-63 ( EudraCT Number )
First Posted: December 15, 2008    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: December 2013
Keywords provided by Astellas Pharma Inc:
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases
Dermatologic Agents
Immunologic Factors
Physiological Effects of Drugs