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QAX576 in Idiopathic Pulmonary Fibrosis
NCT00532233Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2007
- Primary completion
- Jun 2009
- Countries
- 1
- Sponsor
- Novartis
- Modality
- Monoclonal Antibodies
- Drugs
- dectrekumab
- Conditions
- idiopathic pulmonary fibrosis (IPF)
01
Overview
Phase 2, open-label, single-arm trial of dectrekumab in idiopathic pulmonary fibrosis (IPF), sponsored by Novartis. Primary endpoints: Interleukin-13 production at Week 4 and Neutralization of IL-13 by QAX576 at Week 4. Started Sep 2007; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
QAX576
Single Intravenous Dose of QAX576
03
Who it enrols
Men and women aged 40-80 with confirmed idiopathic pulmonary fibrosis, non-smokers, and of non-childbearing potential.
04
Endpoints
Primary
Interleukin-13 production
Neutralization of IL-13 by QAX576
Secondary
Changes in biomarkers in blood
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