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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00426218
Other study ID # CACZ885A2203
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received January 23, 2007
Last updated August 8, 2011
Start date December 2006

Study information

Verified date August 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial Summary

This study is a multi-center, open label, repeated dose, range finding study to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and efficacy of ACZ885, a fully human anti-interleukin-1B (anti-IL-1B) monoclonal antibody, given subcutaneously in pediatric subjects with active SJIA.


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Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
ACZ885


Locations

Country Name City State
Italy Novartis Investigative site Origgio

Sponsors (1)

Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety, tolerability and immunogenicity of subcutaneous (s.c.) ACZ885
Primary To assess the initial efficacy profile of s.c. ACZ885: % responder to treatment and time to relapse and control the systemic manifestations of SJIA such as fever.
Primary pharmacokinetics of ACZ885
Primary To assess pharmacokinetics (PK) / pharmacodynamics (PD) relationships in order to derive a dose and dosing regimen
Secondary proportion of patients with inactive disease at each dose level.
Secondary To investigate the possibility of corticosteroid tapering.
Secondary biomarker and pharmacogenomic characterization of patients at baseline and to evaluate the treatment response to ACZ885.
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