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

Completed · Phase 3 · Has a placebo group

Conditions studied: Muckle Wells Syndrome

In brief

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.

Key facts

Study ID

NCT00465985

Run by

Novartis

People needed

35

Starts

2007-04-01

Last updated by the study team

2017-08-28

Who can join

Age: 4 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Molecular diagnosis of NALP3 mutations and clinical picture resembling Muckle-Wells Syndrome.
• Muckle-Wells Syndrome patients who participated in the CACZ885A2102 study, will have the option to participate in this study upon disease flare
• Muckle-Wells Syndrome patients requiring medical intervention either untreated or treated (i.e. under ACZ885, anakinra, or any other investigational IL-1 blocking therapy).

You may not qualify if…

• 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 the trial, and up to 3 months following the last dose.
• History of significant medical conditions, which in the Investigator's opinion would exclude 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 screening visit or within 2 months prior to the screening visit, according to national guidelines.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — San Francisco, California, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Madison, Wisconsin, United States
• Novartis Investigative Site — Le Kremlin-Bicêtre, France
• Novartis Investigational Site — Lille, France
• Novartis Investigative Site — Montpellier, France
• Novartis Investigative Site — Nantes, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Tübingen, Germany
• Novartis Investigative Site — New Delhi, India
• Novartis Investigative Site — Barcelona, Spain
• Novartis Investigative Site — London, United Kingdom

Full record on ClinicalTrials.gov

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