Clinical trial NCT00532233: SD, IL-13 Production Rate in IPF
Official title: A Open-label, Multicenter Study, With a Single Intravenous Dose of QAX576 to Determine IL-13 Production in Patients With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic Pulmonary Fibrosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-09-20
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: 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

Primary outcomes:
measure: -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
timeFrame: Week 1,2,3 and 4
Secondary outcomes:
measure: -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.
timeFrame: Week 3
Other outcomes:
Locations:
city: Denver
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: New Orleans
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Rochester
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Durham
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Investigative site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References: