A Study to Evaluate the Safety and Efficacy of Efalizumab in Adult Patients With Plaque Psoriasis Involving the Hands and/or Feet

Genentech

Status and phase

Completed

Phase 4

Conditions

Psoriasis

Treatments

Drug: efalizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00312026

ACD3753g

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
Have a history of thrombocytopenia
Have a history of hemolytic anemia
Have a history of clinically significant anemia
Have a WBC count <4,000 cells/uL or >14,000 cells/uL
Have a hematocrit (HCT) <30% or a hemoglobin (Hgb) level <11 g/dL
Have a platelet count <150,000 cells/uL
Have hepatic enzyme levels ≥3 times the upper limit of normal
Have a serum creatinine level ≥2 times the upper limit of normal
Have been exposed to any experimental drugs or treatments within 30 days or 5 half-lives, whichever is longer, prior to the screening visit
Have had any previous exposure to efalizumab
Have been vaccinated with a live virus or live bacteria within the 14 days prior to the first dose of efalizumab
Have any medical condition that, in the judgment of the investigator, would jeopardize the patient's safety following exposure to study drug (efalizumab or placebo equivalent) or would significantly interfere with the patient's ability to comply with the provisions of this protocol