An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab Followed by Efalizumab Taper in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390g

Genentech, Inc.0 sitesJanuary 2002

ConditionsPsoriasis

DrugsRaptiva (efalizumab)

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Psoriasis
Sponsor: Genentech, Inc.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This is an open-label, multicenter study designed to evaluate the efficacy and safety of efalizumab administered at weekly SC (subcutaneous) doses of 1.0 mg/kg followed by efalizumab taper in subjects with plaque psoriasis who previously participated in Study ACD2390g.

Registry

clinicaltrials.gov

Start Date

January 2002

End Date

April 2003

Last Updated

12 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed informed consent
•Previous participation in Study ACD2390g
•For women of childbearing potential, continued use of an acceptable method of contraception for the duration of their participation in the study
•Willingness to continue to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources throughout the study

Exclusion Criteria

•Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to efalizumab
•Systemic therapy for psoriasis (ET Day 0 through FU Day 84 or upon relapse or unusual presentation of psoriasis in the FU period, whichever occurs first)
•Systemic immunosuppressive drugs for other indications (ET Day 0 through FU Day 84)
•Topical therapies for psoriasis (ET Day 0 through ET Day 84)
•Live virus or bacteria vaccines (ET Day 0 through FU Day 84)
•Other vaccines or allergy desensitization (it is recommended that these be scheduled after FU Day 84)
•Other experimental drugs or treatments (ET Day 0 through FU Day 84)
•Beta-Blockers, ACE inhibitors, interferons, quinidine, antimalarial drugs, or lithium (if clinically indicated, such medications are allowed but the dosage should be held constant between ET Day 0 and TT Day 84)