Psoriasis Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

175

Study ID:

NCT00692172

Recruitment Status:

Completed

Sponsor:

Astellas Pharma Inc

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There are 43 Locations for this study

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Hot Springs Arkansas, 71913, United States

Fresno California, 93710, United States

La Jolla California, 92037, United States

Washington District of Columbia, 20010, United States

Jacksonville Florida, 32204, United States

Pinellas Park Florida, 33781, United States

Newnan Georgia, 30263, United States

Chicago Illinois, 60611, United States

Kansas City Kansas, 66160, United States

Clinton Township Michigan, 48038, United States

St. Louis Missouri, 63110, United States

Omaha Nebraska, 68131, United States

Berlin New Jersey, 08009, United States

Lake Oswego Oregon, 79035, United States

Portland Oregon, 97210, United States

Johnston Rhode Island, 02919, United States

Goodlettsville Tennessee, 37072, United States

Austin Texas, 78759, United States

San Antonio Texas, 78229, United States

Brussels , B-107, Belgium

Edegem , B-265, Belgium

Liege , 4000, Belgium

Calgary Alberta, T2S 3, Canada

Winnipeg Manitoba, R3C O, Canada

Moncton New Brunswick, E1C 8, Canada

St. John's Newfoundland and Labrador, A1B 4, Canada

London Ontario, N6A 3, Canada

Waterloo Ontario, N2J 1, Canada

Windsor Ontario, N8W 5, Canada

Sainte-Foy Quebec, G1V 4, Canada

Copenhagen , DK-24, Denmark

Besancon , 25030, France

Brest , 29279, France

Nice , 06202, France

Paris , 75475, France

Tours , 37044, France

Bochum , 44791, Germany

Dresden , 01307, Germany

Munich , 80337, Germany

Amsterdam , 1100 , Netherlands

Madrid , 28006, Spain

Valencia , 46014, Spain

Liverpool , L14 3, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

175

Study ID:

NCT00692172

Recruitment Status:

Completed

Sponsor:


Astellas Pharma Inc

How clear is this clinincal trial information?

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