SD, IL-13 Production Rate in IPF

NCT00532233 | Completed Phase 2

• 1 other identifier: CQAX576A2202
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 6

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).

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis

Outcome Measures

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

  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.

  Week 3

Study Arms (1)

1

EXPERIMENTAL

QAX576

Drug: QAX576

Interventions

QAX576 DRUG

1

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

Novartis Investigative Site

Denver, Colorado, 80206, United States

Location

Novartis Investigative Site

Atlanta, Georgia, 30319, United States

Location

Novartis Investigative Site

New Orleans, Louisiana, 70112, United States

Location

Novartis Investigative Site

Rochester, Minnesota, 55905, United States

Location

Novartis Investigative Site

Durham, North Carolina, 27704, United States

Location

Novartis Investigative Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Links

• Clinical Trial Results for CQAX576A2202 at Novartis Clinical Trials.com

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

• Novartis

  Investigative site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2007
• First Posted: September 20, 2007
• Study Start: September 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: December 19, 2020

Record last verified: 2017-06

Locations

US (6)