SD, IL-13 Production Rate in IPF

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00532233

Enrollment

Registered

2007-09-20

Start date

2007-09-30

Completion date

2009-06-30

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis

Brief summary

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

Interventions

DRUGQAX576

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
-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	Week 1,2,3 and 4

Secondary

Measure	Time frame
-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.	Week 3

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026