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

Completed · Phase 3

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT00692172

Run by

Astellas Pharma Inc

People needed

175

Starts

2001-12-01

Expected to finish

2004-11-01

Last updated by the study team

2014-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Hot Springs, Arkansas, United States
• Study site — Fresno, California, United States
• Study site — La Jolla, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Jacksonville, Florida, United States
• Study site — Pinellas Park, Florida, United States
• Study site — Newnan, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Kansas City, Kansas, United States
• Study site — Clinton Township, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Berlin, New Jersey, United States
• Study site — Lake Oswego, Oregon, United States
• Study site — Portland, Oregon, United States
• Study site — Johnston, Rhode Island, United States
• Study site — Goodlettsville, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Brussels, Belgium
• Study site — Edegem, Belgium
• Study site — Liège, Belgium
• Study site — Calgary, Alberta, Canada
• Study site — Winnipeg, Manitoba, Canada
• Study site — Moncton, New Brunswick, Canada

Full record on ClinicalTrials.gov

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