A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with Muckle-Wells Syndrome

Update Il y a 4 ans
Reference: EUCTR2006-005455-15

Woman and Man

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Extract

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.


Inclusion criteria

  • Muckle-Wells Syndrome (Autoinflammatory Disease)