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

Psoriasis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692172
• Other study ID #: C-728
• Status: Completed
• Phase: Phase 3
• First received: June 4, 2008
• Last updated: September 17, 2014
• Start date: December 2001
• Est. completion date: November 2004

Study information

• Verified date: September 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of MedicinesCanada: Health CanadaNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Belgium: Federal Agency for Medicinal Products and Health ProductsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Denmark: Danish Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Alefacept
intramuscular injection (IM)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Biogen

Countries where clinical trial is conducted

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

References & Publications (1)

Roberts JL, Ortonne JP, Tan JK, Jaracz E, Frankel E; Alefacept Clinical Study Group. The safety profile and sustained remission associated with response to multiple courses of intramuscular alefacept for treatment of chronic plaque psoriasis. J Am Acad Dermatol. 2010 Jun;62(6):968-78. doi: 10.1016/j.jaad.2009.07.032. Epub 2010 Apr 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of safety including evaluation of incidence of adverse events, physical exams and laboratory monitoring		Throughout treatment course	No
Secondary	Proportion of subjects who achieved "Almost Clear" or "Clear" by Physicians' Global Assessment		Every 2 weeks throughout treamtent course	No

External Links

•   Link to Results on JAPIC - enter 140596 in the JapicCTI-RNo. field