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A Double-blind, Randomized, Placebo-controlled, Multicenter Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Systemic Lupus Erythematosus (Sle)

Description

Brief Summary
The objective of this study is to evaluate and compare efficacy of 3 dose levels of PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and exploratory measures as well.


Phase

Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.

Inclusion and Exclusion Criteria

  • Male or female subjects between ages of 18 and 75 years old at time of signing consent.
  • Have a clinical diagnosis of SLE according to 1997 update on the revised 1982 American College of Rheumatology (ACR) criteria.
  • Have a unequivocally positive anti-nuclear antibody (ANA) test result.
  • Active disease at screening defined by both: SLEDAI-2K score greater than or equal to 6 and BILAG Level A disease in more than or equal to 1 organ system (except renal or central nervous system) or BILAG B disease in more than or equal to 2 organ systems if no level A disease in present.

  • Any prior history of treatment with PF-04236921, or anti-IL-6 agent;
  • Have received any of the following within 364 days of day 1: a biologic investigational agent other than B cell targeted therapy; required 3 or more courses of systemic corticosteroids for concomitant conditions; history of previously untreated or current evidence of active or untreated latent infection with Tuberculosis (TB), evidence of prior untreated or currently active TB by chest radiography, residing with or frequent close contact with an individual with active TB.

Sites

  • California

    • Pfizer Investigational Site, Los Angeles, California, 90048
    • Pfizer Investigational Site, Lakewood, California, 90712
    • Pfizer Investigational Site, Long Beach, California, 90813
    • Pfizer Investigational Site, Los Angeles, California, 90095
    • Pfizer Investigational Site, Upland, California, 91786
    • Pfizer Investigational Site, Fair Oaks, California, 95628

  • Nevada

    • Pfizer Investigational Site, Las Vegas, Nevada, 89102

  • New Mexico

    • Pfizer Investigational Site, Albuquerque, New Mexico, 87102

  • Idaho

    • Pfizer Investigational Site, Meridian,, Idaho, 83642

  • Washington

    • Pfizer Investigational Site, Tacoma, Washington, 98405
    • Pfizer Investigational Site, Seattle, Washington, 98133

  • Oklahoma

    • Pfizer Investigational Site, Oklahoma City, Oklahoma, 73104

  • Texas

    • Pfizer Investigational Site, Dallas, Texas, 75390
    • Pfizer Investigational Site, Mesquite, Texas, 75150
    • Pfizer Investigational Site, Houston, Texas, 77004
    • Pfizer Investigational Site, Houston, Texas, 77034

  • Tennessee

    • Pfizer Investigational Site, Jackson, Tennessee, 38305

  • Illinois

    • Pfizer Investigational Site, Chicago, Illinois, 60637

  • Alabama

    • Pfizer Investigational Site, Birmingham, Alabama, 35216
    • Pfizer Investigational Site, Anniston, Alabama, 36207

  • Indiana

    • Pfizer Investigational Site, Indianapolis, Indiana, 46202
    • Pfizer Investigational Site, Granger, Indiana, 46530

  • Georgia

    • Pfizer Investigational Site, Atlanta, Georgia, 30303
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