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

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00312026
First received: April 5, 2006
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: efalizumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • 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 Measures:
  • 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

Estimated Enrollment: 75
Study Start Date: April 2006
Estimated Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312026

Sponsors and Collaborators
Genentech
Investigators
Study Director: Ivor Caro, M.D. Genentech
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00312026     History of Changes
Other Study ID Numbers: ACD3753g
Study First Received: April 5, 2006
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Genentech:
Plaque Psoriasis
Hands
Feet
Hand

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on October 02, 2014