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

NCT00312026 | Completed Phase 4

• 1 other identifier: ACD3753g
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis

Keywords

Plaque Psoriasis; Hands; Feet; Hand

Outcome Measures

Primary Outcomes (1)

• 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 (4)

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

• The proportion of patients who achieve a PGA rating of clear (0) or almost clear (1) at Day 84

• The change from Day 0 to Day 84 in the following PRO measures: SF 36, PDS, Work Loss Questionnaire

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

Interventions

efalizumab DRUG

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

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 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 5, 2006
• First Posted: April 7, 2006
• Study Start: March 30, 2006
• Primary Completion: November 28, 2006
• Study Completion: November 28, 2006
• Last Updated: February 15, 2017

Record last verified: 2017-02