Expired Study
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Louisville, Kentucky 40217


Purpose:

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


Study summary:

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).


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


Study is Available At:


Original ID:

0485-CL-0004


NCT ID:

NCT00808223


Secondary ID:

2008-005830-63


Study Acronym:


Brief Title:

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]


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

12 Years


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Astellas Pharma Inc


Oversight Authority:

  • United States: Food and Drug Administration
  • Bulgaria: Bulgarian Drug Agency
  • Latvia: State Agency of Medicines


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificatio


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Actual


Overall Contact Information

Official Name:Vice President Medical Affairs
Study Director
Astellas Pharma Global Development

Study Dates

Start Date:April 2009
Completion Date:February 2012
Completion Type:Actual
Primary Completion Date:February 2012
Primary Completion Type:Actual
Verification Date:December 2013
Last Changed Date:December 10, 2013
First Received Date:December 11, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Assessment of Pharmacokinetics through analysis of blood samples (only approximately first 24 subjects enrolled)
Time Frame:4 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Assessment of Pharmacodynamics: Total lymphocytes and lymphocyte subsets
Time Frame:4 Weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Assessment of Physical exams, vital signs, select blood chemistry and hematology, lymphocyte subset analysis, anti-alefacept antibody monitoring, adverse event monitoring including infections.
Time Frame:6 months
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:alefacept
Description:IM injection
Arm Name:1. alefacept
Other Name:Amevive

Study Arms

Study Arm Type:Experimental
Arm Name:1. alefacept

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Astellas Pharma Inc

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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