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

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00808223

Purpose

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

Condition	Intervention	Phase
Psoriasis	Biological: alefacept	Phase II

MedlinePlus related topics: Psoriasis

Drug Information available for: Alefacept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
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]

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of Pharmacodynamics: Total lymphocytes and lymphocyte subsets [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Assessment of Pharmacokinetics (only approximately first 12 subjects enrolled) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	January 2009
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. alefacept: Experimental	Biological: alefacept IM injection

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.

Eligibility

Ages Eligible for Study:	12 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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
Subject has a history of tuberculosis or a positive PPD skin test
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808223

Contacts

Contact: Astellas Pharma US Medical Information

800-888-7704 ext 5473

clintrials.info@us.astellas.com

Locations

United States, California

San Diego, California, United States, 92123
United States, Kentucky

Louisville, Kentucky, United States, 40217
Bulgaria

Pleven, Bulgaria, 5800

Plovdiv, Bulgaria, 4004

Rousse, Bulgaria, 7000

Sofia, Bulgaria
Latvia

Riga, Latvia, 1004

Riga, Latvia, 1002

Riga, Latvia, 1001

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Use Central Contact

Astellas Pharma US, Inc.

More Information

Responsible Party:	Astellas Pharma US, Inc. ( Sr Manager Clinical Trials Registry )
Study ID Numbers:	0485-CL-0004, EudraCT # 2008-005830-63
Study First Received:	December 11, 2008
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00808223
Health Authority:	United States: Food and Drug Administration; Bulgaria: Bulgarian Drug Agency; Latvia: State Agency of Medicines

Keywords provided by Astellas Pharma Inc:

alefacept
adolescent
psoriasis

Study placed in the following topic categories:

Alefacept
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Therapeutic Uses
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009