Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.