Clinical trial NCT00808223: Safety and Pharmacokinetics (PK) of Alefacept in Adolescent Subjects With Moderate to Severe Psoriasis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: alefacept
adolescent
psoriasis
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-12-15
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Assessment of Physical exams, vital signs, select blood chemistry and hematology, lymphocyte subset analysis, anti-alefacept antibody monitoring, adverse event monitoring including infections.
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of Pharmacodynamics: Total lymphocytes and lymphocyte subsets
timeFrame: 4 Weeks
measure: Assessment of Pharmacokinetics through analysis of blood samples (only approximately first 24 subjects enrolled)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Pediatric and Adolescent Dermatology
state: California
city: Louisville
country: United States
facility: Physicians Skin Care, PLLC
state: Kentucky
city: Sofia
country: Bulgaria
facility: First Municipal Hospital for Active Treatment - Sofia
city: Riga
country: Latvia
facility: Skin and STD Clinical Centre
city: Riga
country: Latvia
facility: Department of Dermatology No.17, Children Clinical Hospital
Study officials:
affiliation: Astellas Pharma Global Development
name: Vice President Medical Affairs
role: STUDY_DIRECTOR
References: