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

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]

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Biological: alefacept

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).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1000
    • First Municipal Hospital for Active Treatment - Sofia
• Latvia
  • Riga, Latvia, 1001
    • Skin and STD Clinical Centre
  • Riga, Latvia, 1004
    • Department of Dermatology No.17, Children Clinical Hospital
• United States
  • California
    • San Diego, California, United States, 92123
      • Pediatric and Adolescent Dermatology
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Physicians Skin Care, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1. alefacept	Biological: alefacept; IM injection; Other Names: Amevive; ASP0485

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of Pharmacodynamics: Total lymphocytes and lymphocyte subsets	4 Weeks
Assessment of Pharmacokinetics through analysis of blood samples (only approximately first 24 subjects enrolled)	4 weeks

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Investigators: Study Director: Vice President Medical Affairs, Astellas Pharma Global Development

Publications and helpful links

Helpful Links

• Link to Results on JAPIC

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: December 11, 2008
• First Submitted That Met QC Criteria: December 12, 2008
• First Posted (Estimate): December 15, 2008

Study Record Updates

• Last Update Posted (Estimate): December 12, 2013
• Last Update Submitted That Met QC Criteria: December 10, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: adolescent; psoriasis; alefacept
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Immunologic Factors; Dermatologic Agents; Alefacept
• Other Study ID Numbers: 0485-CL-0004; 2008-005830-63 (EudraCT Number)