A Study to Evaluate Efalizumab in Adults With Plaque Psoriasis, Including Those Who Are Receiving Concomitant Antipsoriatic Therapies

NCT00338143 | Completed Phase 3

• 1 other identifier: ACD2782g
• Study Type: interventional
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase IIIb, open label, uncontrolled, multicenter study designed to evaluate the safety and tolerability of 12 weeks of subcutaneously administered efalizumab in subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy and may also be receiving topical therapies, PUVA, or UVB phototherapy during the efalizumab treatment period.

Conditions

Psoriasis

Keywords

Plaque psoriasis; Antipsoriatic

Interventions

efalizumab DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Plaque psoriasis covering \>=10% of total BSA
• Plaque psoriasis diagnosed for at least 6 months
• In the opinion of the investigator, a candidate for systemic therapy for psoriasis
• years old
• Body weight \<=125 kg
• For women of childbearing potential, use of an acceptable method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study and for 3 months after the last dose of efalizumab

You may not qualify if:

• Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
• Pregnancy or lactation
• Clinically significant psoriasis flare during screening or at the time of enrollment
• History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
• History of opportunistic infections (e.g., systemic fungal infections, parasites)
• Seropositivity for hepatitis B or C virus
• Seropositivity for human immunodeficiency virus (HIV)
• History of active tuberculosis (TB) or currently undergoing treatment for TB
• Presence or history of malignancy within the past 5 years, including lymphoproliferative disorders
• Previous treatment with efalizumab (anti-CD11a)
• Diagnosis of hepatic cirrhosis, regardless of cause or severity
• Hospital admission for cardiovascular or pulmonary disease within the last year
• History of severe allergic or anaphylactic reactions to monoclonal antibodies or fusion proteins, which contain an Ig Fc region (e.g., etanercept, alefacept)
• History of treatment with lymphocyte-depleting monoclonal antibodies or immunoadhesion molecules (e.g., anti-CD4, CTLA4-Ig, alefacept)
• White blood cell (WBC) count \< 4000/uL or \> 14,000/uL

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Psoriasis

Interventions

efalizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ivor Caro, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2006
• First Posted: June 20, 2006
• Study Start: October 1, 2003
• Study Completion: May 1, 2004
• Last Updated: March 4, 2014

Record last verified: 2014-02