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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00692172
• Date of registration: 04/06/2008
• Prospective Registration: No
• Primary sponsor: Astellas Pharma Inc
• Public title: Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque Psoriasis
• Scientific title: 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
• Date of first enrolment: December 2001
• Target sample size: 175
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00692172
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Central Contact
• Affiliation: Astellas Pharma US, Inc.

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Psoriasis

Intervention(s)

Drug: Alefacept

Primary Outcome(s)

Assessment of safety including evaluation of incidence of adverse events, physical exams and laboratory monitoring [Time Frame: Throughout treatment course]

Secondary Outcome(s)

Proportion of subjects who achieved "Almost Clear" or "Clear" by Physicians' Global Assessment [Time Frame: Every 2 weeks throughout treamtent course]

Secondary ID(s)

C-728

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Biogen Idec