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

NCT00808223 | Completed Phase 2 DMC

• 2 other identifiers: 0485-CL-00042008-005830-63
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 5

Brief Summary

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

Conditions

Psoriasis

Keywords

alefacept; adolescent; psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

1. alefacept

EXPERIMENTAL

Biological: alefacept

Interventions

alefacept BIOLOGICAL

IM injection

Also known as: Amevive, ASP0485

1. alefacept

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (5)

Pediatric and Adolescent Dermatology

San Diego, California, 92123, United States

Location

Physicians Skin Care, PLLC

Louisville, Kentucky, 40217, United States

Location

First Municipal Hospital for Active Treatment - Sofia

Sofia, 1000, Bulgaria

Location

Skin and STD Clinical Centre

Riga, 1001, Latvia

Location

Department of Dermatology No.17, Children Clinical Hospital

Riga, 1004, Latvia

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Alefacept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CD58 Antigens; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Membrane Proteins; Recombinant Fusion Proteins; Recombinant Proteins

Study Officials

• Vice President Medical Affairs

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2008
• First Posted: December 15, 2008
• Study Start: April 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

LA (2); US (2); BU (1)