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OpenTrials
Completed

NCT Number: NCT00532233

SD, IL-13 Production Rate in IPF

The purpose of this study is to investigate how QAX576 affects levels of interleukin 13 (IL-13) in patients with idiopathic pulmonary fibrosis (IPF).

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Denver, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women between the ages of 40 and 80 years with a confirmed diagnosis of idiopathic pulmonary fibrosis
  • Both men and women must be on non-childbearing potential. Additional information regarding this requirement is available at screening.
  • Capability to meet certain lung function tests at screening
  • Non-smokers
  • No participation in another clinical study within 4 weeks of study start.

Exclusion criteria

  • Certain medical conditions may exclude candidates from participation.
  • Blood loss or donation of 400 mL or more within 2 months of study start Significant illness (other than respiratory) within 2 weeks of study start
  • Past medical personal or close family history of clinically significant ECG abnormalities
  • Connective tissue disorders
  • Active infection or history of systemic parasitic infection
  • Known hypersensitivity to the drug.
  • History of immunocompromise, including a positive HIV test result.
  • History of drug or alcohol abuse within 12 months of study start
  • Any condition that may compromise patient safety

Treatment and study plan

QAX576

Drug

Primary outcomes

  1. -To investigate the possibility that some IPF patients experience increased IL-13 production. Blood samples to be collected pre-dose and weekly after dosing. -To investigate the hypothesis that QAX576 will neutralize IL-13 in patients with IPF

    Time frame: Week 1,2,3 and 4

Secondary outcomes

  1. -To evaluate the changes in biomarkers in blood over time in patients with IPF. Serum samples will be obtained at pre-dose and 2 weeks post-dose.

    Time frame: Week 3

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Open-label, Multicenter Study, With a Single Intravenous Dose of QAX576 to Determine IL-13 Production in Patients With Idiopathic Pulmonary Fibrosis

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 20, 2007
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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