NCT00808223

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

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]

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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

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. If a dose adjustment is required, pharmacokinetics will be repeated for the first 12 subjects enrolled at the new dose (subjects 13-24).

Conditions

• Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	alefacept	IM injection

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2008-12-15
• Last updated: 2013-12-12

Locations

5 sites across 3 countries: United States, Bulgaria, Latvia