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

An Open-Label, Multi-center Study to Evaluate the Safety and Tolerability of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Subjects With Chronic Plaque Psoriasis Who Have Completed Studies C99-717 or C99-712

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00692172

Enrollment

175

Registered

2008-06-06

Start date

2001-12-31

Completion date

2004-11-30

Last updated

2014-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

psoriasis, alefacept, intramuscular

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.

Interventions

DRUGAlefacept

intramuscular injection (IM)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

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

Countries

Belgium, Canada, Denmark, France, Germany, Netherlands, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026