Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome

Last updated: July 28, 2017
Sponsor: Novartis
Overall Status: Completed

Phase

3

Condition

Skin Wounds

Soft Tissue Infections

White Cell Disorders

Treatment

N/A

Clinical Study ID

NCT00465985
CACZ885D2304
  • Ages 4-75
  • All Genders

Study Summary

This study is designed to provide efficacy and safety data for ACZ885 (a fully human anti-interleukin-1beta (anti-IL-1beta) monoclonal antibody) administered as an injection subcutaneously (s.c.) in patients with Muckle-Wells Syndrome.

Part I is an 8-week open-label, active treatment period to identify ACZ885 responders.

Part II is a double-blind, placebo-controlled period to assess primarily the efficacy of ACZ885 compared to placebo.

Part III is an open-label, active treatment period where patients will receive ACZ885 every 8 weeks after withdrawal or completion of Part II.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Molecular diagnosis of NALP3 mutations and clinical picture resembling Muckle-WellsSyndrome.

  • Muckle-Wells Syndrome patients who participated in the CACZ885A2102 study, will havethe option to participate in this study upon disease flare

  • Muckle-Wells Syndrome patients requiring medical intervention either untreated ortreated (i.e. under ACZ885, anakinra, or any other investigational IL-1 blockingtherapy).

Exclusion

Exclusion Criteria:

  • History of being immunocompromised, including a positive HIV at screening test result.

  • No live vaccinations within 3 months prior to the start of the trial, during thetrial, and up to 3 months following the last dose.

  • History of significant medical conditions, which in the Investigator's opinion wouldexclude the patient from participating in this trial.

  • History of recurrent and/or evidence of active bacterial, fungal, or viral infections.

  • Positive tuberculin skin test at 48 to 72 hours after administration at the screeningvisit or within 2 months prior to the screening visit, according to nationalguidelines. Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 35
Study Start date:
April 01, 2007
Estimated Completion Date:

Connect with a study center

  • Novartis Investigative Site

    Le Kremlin Bicetre,
    France

    Site Not Available

  • Novartis Investigational Site

    Lille Cedex,
    France

    Site Not Available

  • Novartis Investigative Site

    Montpellier Cedex,
    France

    Site Not Available

  • Novartis Investigative Site

    Nantes,
    France

    Site Not Available

  • Novartis Investigative Site

    Paris,
    France

    Site Not Available

  • Novartis Investigative Site

    Tubingen,
    Germany

    Site Not Available

  • Novartis Investigative Site

    New Delhi,
    India

    Site Not Available

  • Novartis Investigative Site

    Barcelona,
    Spain

    Site Not Available

  • Novartis Investigative Site

    London,
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    San Francisco, California 94115
    United States

    Site Not Available

  • Novartis Investigative Site

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Novartis Investigative Site

    Madison, Wisconsin 53792
    United States

    Site Not Available

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