Conditions: Muckle Wells Syndrome
Keywords: Muckle-Wells Syndrome children systemic autoinflammatory disease CIAS-1 gene NALP-3 ACZ885 human monoclonal anti-human interleukin-1beta (IL-1beta) antibody autosomal dominant familial autoinflammatory syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 35
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: ACZ885 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: