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Clinical Study With QAX576 in Patients With Idiopathic Pulmonary Fibrosis Overview

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Pulmonary fibrosis is a condition in which tissue deep in your lungs becomes thick and stiff, or scarred, over time. The development of the scarred tissue is called fibrosis.

In some cases, doctors can find out what is causing the fibrosis. But in most cases, they can't. They call these cases idiopathic pulmonary fibrosis, or IPF for short. Current treatment options for this condition are limited.

There is a compound called IL-13 that plays a role in the scarring seen in IPF. But there is still a lot to learn about IPF. For example, it is not known whether people with IPF have high levels of IL-13.

Novartis Pharmaceuticals is sponsoring a clinical study to help answer the question of whether people with IPF have high levels of IL-13. This study is being conducted at six medical centers in the United States.

If you would like to learn more about this study, the next step is to set up an appointment with a study team. During your first appointment, the team will provide more study details to you. This includes possible risks and benefits and your responsibilities, among other things. This is known as the informed consent process.

If you agree to participate, the study team will then perform several additional tests to make sure that you meet the qualifications. If you meet them, you will be officially enrolled in the study.

Participants enrolled will then come to the study center at least five times over a period of about 29 days. On the first visit after enrollment, they will receive an experimental medication through an IV. Each week thereafter, a blood sample will be taken to measure the level of IL-13 in the blood.

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Clinical Study With QAX576 in Patients With Idiopathic Pulmonary Fibrosis

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

Condition: Idiopathic pulmonary fibrosis (IPF)

Study Type: Interventional using the drug QAX576

Phase: Phase II

Official Title: An Open-Label, Multi-Center Study, With a Single Intravenous Dose of QAX576 to Determine IL-13 Production in Patients With Idiopathic Pulmonary Fibrosis.

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

Secondary Outcome Measures: 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.

Number of Sites Participating: 6

Estimated Enrollment: 50

Study Start Date: October 2007

Estimated Study Completion Date: July 2008

Eligibility:

Age: 40 to 80 years of age

Gender Eligible for Study: Both

Accepts Healthy Volunteers: No

Inclusion Criteria:

Men and women between the ages of 40 and 80 years with a confirmed diagnosis of idiopathic pulmonary fibrosis (IPF).
Women must be of nonchildbearing 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.