Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque Psoriasis

Phase 3

Completed

• Conditions: Psoriasis
• Interventions: Drug: Alefacept

• Registration Number: NCT00692172
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

An extension study to evaluate safety and tolerability of up to 3 additional courses of IM alefacept in patients with chronic plaque psoriasis who have been previously treated with 1 or 2 courses of IM alefacept.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-12
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2008-06-04
• Study First Posted: 2008-06-06
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• Must have received at least 8 injections in the C99-717 study and completed the final follow-up visit OR,
• Must have completed the C99-712 study and been in C99-717 interim visits at the time dosing in the C99-717 study was closed. A subject who completed C99-712 but did not participate in any part of C99-717, including interim visits, must have prior sponsor approval before admission into C-728

Exclusion Criteria

• Nursing mothers, pregnant women, and women planning to become pregnant while on study are to be excluded. Female patients who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study
• Clinically significant abnormal hematology values or history of an immunosuppressive disorder
• Serious local infection or systemic infection within 3 months prior to the first dose of alefacept
• A significant change in the subject's medical history from their previous alefacept study
• Any subject who initiated alternative systemic therapy, phototherapy, or disallowed therapy prior to visit 8 in study C99-712 or C99-717
• Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Alefacept	-

Primary Outcome Measures

Name	Time	Method
Assessment of safety including evaluation of incidence of adverse events, physical exams and laboratory monitoring	Throughout treatment course

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects who achieved "Almost Clear" or "Clear" by Physicians' Global Assessment	Every 2 weeks throughout treamtent course