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 |
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).
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