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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00312026
• Date of registration: 05/04/2006
• Primary sponsor: Genentech
• Public title: A Study to Evaluate the Safety and Efficacy of Efalizumab in Adult Patients With Plaque Psoriasis Involving the Hands and/or Feet
• Scientific title: 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
• Date of first enrolment: April 2006
• Target sample size: 75
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00312026
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Ivor Caro, M.D.
• Affiliation: Genentech

Key inclusion & exclusion 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

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Psoriasis

Intervention(s)

Drug: efalizumab

Primary Outcome(s)

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 Outcome(s)

The change from Day 0 in PGA rating (i.e., the number of categories changed) at Day 84

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 proportion of patients who achieve a PGA rating of clear (0), almost clear (1), or mild (2) at Day 42

Secondary ID(s)

ACD3753g

Source(s) of Monetary Support

Please refer to primary and secondary sponsors