Safety and Pharmacokinetics (PK) of Alefacept in Adolescent Subjects With Moderate to Severe Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00808223
First received: December 11, 2008
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Psoriasis
Biological: alefacept
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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]

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of Pharmacodynamics: Total lymphocytes and lymphocyte subsets [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Assessment of Pharmacokinetics through analysis of blood samples (only approximately first 24 subjects enrolled) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. alefacept Biological: alefacept
IM injection
Other Names:
  • Amevive
  • ASP0485

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).

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00808223

Locations
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
Bulgaria
First Municipal Hospital for Active Treatment - Sofia
Sofia, Bulgaria, 1000
Latvia
Department of Dermatology No.17, Children Clinical Hospital
Riga, Latvia, 1004
Skin and STD Clinical Centre
Riga, Latvia, 1001
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Vice President Medical Affairs Astellas Pharma Global Development
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00808223     History of Changes
Other Study ID Numbers: 0485-CL-0004, 2008-005830-63
Study First Received: December 11, 2008
Last Updated: December 10, 2013
Health Authority: United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency
Latvia: State Agency of Medicines

Keywords provided by Astellas Pharma Inc:
alefacept
adolescent
psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Alefacept
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014