A Phase IV Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 1.0 mg/kg Efalizumab in Adult Patients With Moderate to Severe Plaque Psoriasis Involving the Hands and/or Feet

Genentech, Inc.0 sites75 target enrollmentMarch 30, 2006

ConditionsPsoriasis

Drugsefalizumab

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Psoriasis
Sponsor: Genentech, Inc.
Enrollment: 75
Primary Endpoint: The primary efficacy outcome measure is the proportion of patients who achieve a PGA rating of clear (0), almost clear (1), or mild (2) at Day 84.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This is a Phase IV randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of SC efalizumab in adult patients (18 years of age and older) with chronic moderate to severe plaque psoriasis involving the hands and/or feet who have had no previous exposure to efalizumab. The study will consist of a screening period, a treatment period, and an observation period.

Registry

clinicaltrials.gov

Start Date

March 30, 2006

End Date

November 28, 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genentech, Inc.

Eligibility Criteria

Inclusion Criteria

•Provide written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) documents
•Be aged 18 years or older
•Have chronic (6 months or greater) moderate to severe plaque psoriasis involving the hands and/or feet with or without pustules and with or without psoriasis at other sites
•Have a PGA rating of moderate (3) or severe (4) for hand and/or foot psoriasis
•Be a candidate for systemic therapy in the opinion of the investigator
•Be naive to efalizumab treatment
•Weigh no more than 125 kg
•For women of childbearing potential, use a method of contraception acceptable to the investigator to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study and for 6 weeks after the last dose of efalizumab

Exclusion Criteria

•Have a history of hypersensitivity to efalizumab or any of its components
•Are using any excluded therapy
•Have a history of or ongoing alcohol or illegal drug abuse
•Have a history of or an ongoing uncontrolled serious bacterial, viral, fungal, or atypical mycobacterial infection. This includes diagnoses that required more than 2 weeks of therapy, such as endocarditis and osteomyelitis, that have been treated in the past 6 months. In addition, if the patient is currently receiving antibiotics, antivirals, or antifungals for an infection or for suppression or prophylaxis for any diagnosis, the patient will be excluded.
•Have any history of opportunistic infections (e.g., systemic fungal infections, parasites)
•Are seropositive for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency virus (HIV). Patients will undergo testing during screening, and any patients who are seropositive for hepatitis B antigen, hepatitis C antibody, or HIV will be excluded.
•Have a history of active tuberculosis or are currently undergoing treatment for tuberculosis. A purified protein derivative (PPD) test or chest x-ray will be performed at the screening visit. Patients with a positive PPD test (not due to BCG vaccination) or chest x-ray will be excluded.
•Have the presence or history of malignancy within the past 5 years, including lymphoproliferative disorders. Patients with a history of fully resolved basal or squamous cell skin cancer may be enrolled.
•Are pregnant or lactating women
•Have a diagnosis of hepatic cirrhosis, regardless of cause or severity

Outcomes

Primary Outcomes

The primary efficacy outcome measure is the proportion of patients who achieve a PGA rating of clear (0), almost clear (1), or mild (2) at Day 84.

Secondary Outcomes

The change from Day 0 to Day 84 in the following PRO measures: SF 36, PDS, Work Loss Questionnaire
The proportion of patients who achieve a PGA rating of clear (0) or almost clear (1) at Day 84
The change from Day 0 in PGA rating (i.e., the number of categories changed) at Day 84
The proportion of patients who achieve a PGA rating of clear (0), almost clear (1), or mild (2) at Day 42