A Study to Evaluate Raptiva in Adults With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00109317
First received: April 27, 2005
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

This is a Phase IIIb, randomized, double-blind, parallel-group, placebo-controlled, multicenter study designed to evaluate the safety and tolerability of efalizumab administered subcutaneously at weekly doses of 1.0 mg/kg in subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.


Condition Intervention Phase
Psoriasis
Drug: Raptiva (efalizumab)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase IIIb, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab in Adults With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Enrollment: 686
Study Start Date: September 2002
Study Completion Date: February 2003
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Plaque psoriasis covering >=10% of total BSA
  • Diagnosis of plaque psoriasis for at least 6 months
  • Minimal PASI score of 12.0 at screening
  • In the opinion of the investigator, candidate for systemic therapy for psoriasis who has not been previously treated (naive to systemic treatment) or prior treatment with systemic therapy for psoriasis (e.g., PUVA, cyclosporine, corticosteroids, methotrexate, oral retinoids, MMF, thioguanine, hydroxyurea, sirolimus, azathioprine, 6-MP, etanercept)
  • Body weight of <=140 kg
  • 18 to 75 years old
  • For women of childbearing potential, willingness to use an acceptable method of contraception to prevent pregnancy for the duration of the study
  • Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study
  • Willingness to enter Study ACD2601g

Exclusion Criteria:

  • Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
  • History of severe allergic or anaphylactic reactions to humanized monoclonal antibodies or fusion proteins that contain an Ig Fc region
  • Clinically significant psoriasis flare during screening or on the day of randomization
  • History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
  • History of opportunistic infections (e.g., systemic fungal infections, parasites)
  • Seropositivity for human immunodeficiency virus (HIV)
  • Pregnancy or lactation
  • WBC count <4000/uL or >14,000/uL
  • Seropositivity for hepatitis B or C virus
  • Hepatic enzymes >=3x the upper limits of normal (ULN)
  • History of active tuberculosis (TB) or currently undergoing treatment for TB
  • Presence of malignancy within the past 5 years, including lymphoproliferative disorders
  • Previous treatment with efalizumab (anti-CD11a)
  • Diagnosis of hepatic cirrhosis, regardless of cause or severity
  • Serum creatinine >=2x the ULN
  • Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year
  • History of substance abuse within the last 5 years
  • Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00109317     History of Changes
Other Study ID Numbers: ACD2600g
Study First Received: April 27, 2005
Last Updated: June 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
Moderate Plaque Psoriasis
Severe Plaque Psoriasis
Topical

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

ClinicalTrials.gov processed this record on October 20, 2014