SD, IL-13 Production Rate in IPF

Novartis

Status and phase: Completed; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: QAX576

Study type: Interventional

Funder types: Industry

Identifiers

NCT00532233

CQAX576A2202

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

1

Experimental group

Description:

QAX576

Treatment:

Drug: QAX576