A Study to Evaluate Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390g

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.

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)