A Study to Evaluate Raptiva in Adults With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy

NCT00109317 | Completed Phase 3

• 1 other identifier: ACD2600g
• Study Type: interventional
• Target: 686
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase IIIb, randomized, double-blind, parallel-group, placebo-controlled, multicenter study designed to evaluate the safety and tolerability of efalizumab administered subcutaneously at weekly doses of 1.0 mg/kg in subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Conditions

Psoriasis

Keywords

Moderate Plaque Psoriasis; Severe Plaque Psoriasis; Topical

Interventions

Raptiva (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
• Diagnosis of plaque psoriasis for at least 6 months
• Minimal PASI score of 12.0 at screening
• In the opinion of the investigator, candidate for systemic therapy for psoriasis who has not been previously treated (naive to systemic treatment) or prior treatment with systemic therapy for psoriasis (e.g., PUVA, cyclosporine, corticosteroids, methotrexate, oral retinoids, MMF, thioguanine, hydroxyurea, sirolimus, azathioprine, 6-MP, etanercept)
• Body weight of \<=140 kg
• to 75 years old
• For women of childbearing potential, willingness to use an acceptable method of contraception to prevent pregnancy for the duration of the study
• Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study
• Willingness to enter Study ACD2601g

You may not qualify if:

• Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
• History of severe allergic or anaphylactic reactions to humanized monoclonal antibodies or fusion proteins that contain an Ig Fc region
• Clinically significant psoriasis flare during screening or on the day of randomization
• History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
• History of opportunistic infections (e.g., systemic fungal infections, parasites)
• Seropositivity for human immunodeficiency virus (HIV)
• Pregnancy or lactation
• WBC count \<4000/uL or \>14,000/uL
• Seropositivity for hepatitis B or C virus
• Hepatic enzymes \>=3x the upper limits of normal (ULN)
• History of active tuberculosis (TB) or currently undergoing treatment for TB
• Presence 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
• Serum creatinine \>=2x the ULN

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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2005
• First Posted: April 27, 2005
• Study Start: September 1, 2002
• Study Completion: February 1, 2003
• Last Updated: June 21, 2013

Record last verified: 2013-06