Alefacept in Subjects With Chronic Plaque Psoriasis Who Failed to Respond to Anti-TNF Therapy

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Study Status:

Duke University Health System Institutional Review Board has received notification of study termination; final IRB closure date is 12/12/2008. Study enrollment is now closed.

Enrollment Update:

Only one subject was entered into this study out of an expected enrollment of 15 patients in this single site clinical trial. With no recruitment interest, the financial sponsor and Sponsor-PI chose to close the clinical trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John Murray
• Collaborator: Astellas Pharma US, Inc.
• Treatments: Alefacept

Criteria

Inclusion Criteria:

• Men and women between ages of 18 and 80 years

• Subjects diagnosed with chronic plaque psoriasis who require systemic therapy.

• Must be receiving anti-TNF treatment without achieving response of 'almost clear' or 'clear' according to PGA or has not responded with 75% reduction PASI score.

• Must be willing to receive up to 20 weeks of IM injections weekly

• CD4 counts must be above 250 cells/mm3 at screening

Exclusion Criteria:

• Diagnosis of unstable erythroderma or pustular psoriasis or guttate psoriasis

• Serious local infection or systemic infection 3 months prior to receiving study drug.

• Subjects with CD4 lymphocyte count less than 250 cells/mm3 at study entry