A Phase 2, Single-Arm Study to Evaluate the Safety and Pharmacokinetics of Alefacept in Adolescent Subjects with Moderate to Severe Psoriasis

Conditions: Moderate to severe chronic plaque psoriasis
MedDRA version: 9.1Level: LLTClassification code 10037153Term: Psoriasis

Registration Number: EUCTR2008-005830-63-BG

Lead Sponsor: Astellas Pharma Global Development, Inc. (APGD)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 55

Inclusion Criteria

1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent /(Assent, if applicable) and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable). Guardian or proxy consenter informed consent has been obtained for pediatric studies.

2. Subject is male or female, between and inclusive of 12-17 years of age at baseline.

3. Subject has moderate to severe chronic plaque psoriasis involving at least 10% or greater body surface area (where the subject’s hand [palm plus digits] represents approximately 1% of the body surface area).

4. Subject is a candidate for systemic treatment or phototherapy.

5. Subject is in good health (as determined by the investigator) and alefacept is not
contraindicated.

6. Subject must have absolute total CD4+ lymphocyte counts within the normal range at screening.

7. 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.

8. Subject must have predosing laboratory findings without clinically significant abnormal values for hematocrit, hemoglobin, platelets, white blood count and differential, serum creatinine, bilirubin, ALT and AST.

9. Subject must have completed all standard childhood immunizations at least 12 weeks prior to the first dose.

10. Subject meets medication washout requirements and agrees to follow medication restrictions during the study (see Appendix 1).

11. Subject agrees to comply with the study requirements and agrees to come to the clinic for required study visits.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subject has a primary dermatological diagnosis of psoriasis other than plaque psoriasis (e.g., erythrodermic, guttate, pustular or palmar/plantar pustulosis).

2. Subject has a known hypersensitivity to alefacept or any excipient of the study medication.

3. Subject has had a serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 12 weeks prior to the first dose of study drug.

4. Subject has a fever (body temperature = 38°C (or >37 ºC 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.

5. Subject is known to be positive for HIV antibodies.

6. 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), human immunodeficiency virus (HIV) antibody or, in Europe, tubercle bacillus (TB) at Screening.

7. Subject has a history or evidence of tuberculosis based on serology or a positive PPD skin test at Screening.

8. Subject has had treatment with any immunosuppressant agent within 12 weeks, any antibody or immunoglobulin within 24 weeks, or any investigational drug or approved therapy for investigational use within 8 weeks prior to the first dose of study drug.

9. Subject is currently enrolled in any other study and/or previous participation in this study.

10. 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.

11. Subject has a history of malignancy (other than non-melanoma skin cancers).

12. Subject has a chronic condition (e.g., diabetes or hypertension) which is not well controlled.

13. Subject is pregnant or nursing.

14. Subject has any concurrent illness which, in the opinion of the investigator, may interfere with treatment or evaluation of safety.

15. Subject has a history of severe allergic or anaphylactic reactions.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish the safety of alefacept when administered to adolescent subjects with moderate to severe psoriasis;Secondary Objective: To determine the pharmacodynamic effect of alefacept on peripheral blood lymphocygtes and lymphocyte subjects when administered to adolescent subjects.<br><br>To determine the pharmacokinetics of alefacept when administered to adolescent subjects in a subset of the study population of adolescent subjects<br><br>Additional objective: <br>To determine the efficacy of alefacept when administered to adolescent subjects with<br>moderate to severe psoriasis.;Primary end point(s):

Secondary Outcome Measures