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

Psoriasis Clinical Trial

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808223
• Other study ID #: 0485-CL-0004
• Secondary ID: 2008-005830-63
• Status: Completed
• Phase: Phase 2
• First received: December 11, 2008
• Last updated: December 10, 2013
• Start date: April 2009
• Est. completion date: February 2012

Study information

• Verified date: December 2013
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBulgaria: Bulgarian Drug AgencyLatvia: State Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• alefacept
IM injection

Locations

Country	Name	City	State
Bulgaria	First Municipal Hospital for Active Treatment - Sofia	Sofia
Latvia	Department of Dermatology No.17, Children Clinical Hospital	Riga
Latvia	Skin and STD Clinical Centre	Riga
United States	Physicians Skin Care, PLLC	Louisville	Kentucky
United States	Pediatric and Adolescent Dermatology	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

United States,  Bulgaria,  Latvia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Assessment of Pharmacodynamics: Total lymphocytes and lymphocyte subsets		4 Weeks	No
Secondary	Assessment of Pharmacokinetics through analysis of blood samples (only approximately first 24 subjects enrolled)		4 weeks	No

External Links

•   Link to Results on JAPIC