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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Muckle Wells Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part I, Part II-arm1, & Part III

Group Type EXPERIMENTAL

ACZ885

Intervention Type DRUG

Part II - arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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ACZ885

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No