Safety and Pharmacokinetics (PK) of Alefacept in Adolescent Subjects With Moderate to Severe Psoriasis
Phase 2
Completed
- Conditions
- Psoriasis
- Interventions
- Biological: alefacept
- Registration Number
- NCT00808223
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
To establish the safety of alefacept when administered to adolescent subjects with moderate to severe psoriasis.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1. alefacept alefacept -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (5)
Skin and STD Clinical Centre
🇱🇻Riga, Latvia
First Municipal Hospital for Active Treatment - Sofia
🇧🇬Sofia, Bulgaria
Pediatric and Adolescent Dermatology
🇺🇸San Diego, California, United States
Department of Dermatology No.17, Children Clinical Hospital
🇱🇻Riga, Latvia
Physicians Skin Care, PLLC
🇺🇸Louisville, Kentucky, United States