NCT00465985

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

A Three-part,Multicenter Study,With a Randomized,Double-blind,Placebo Controlled,Withdrawal Design in Part II to Assess Efficacy,Safety,and Tolerability of ACZ885(Anti-interleukin-1beta Monoclonal Antibody)in Patients With Muckle-Wells Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 4 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Muckle Wells Syndrome

Interventions

Type	Name	Description
DRUG	ACZ885
DRUG	Placebo

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-10-01
• First posted: 2007-04-27
• Last updated: 2017-08-28
• Results posted: 2011-02-11

Locations

12 sites across 6 countries: United States, France, Germany, India, Spain, United Kingdom