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



Status:Archived
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:May 2009
End Date:December 2011

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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]


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


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).


We found this trial at
4
sites
Louisville, Kentucky
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Louisville, KY
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Celebration, Florida
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Celebration, FL
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Lima, OH
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Santa Clara, California 95051
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Santa Clara, CA
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