SD, IL-13 Production Rate in IPF

December 11, 2020 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80206
        • Novartis Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30319
        • Novartis Investigative Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Novartis Investigative Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Novartis Investigative Site
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • Novartis Investigative Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
QAX576
Drug: QAX576

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: Week 1,2,3 and 4
Week 1,2,3 and 4

Secondary Outcome Measures

Outcome 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.
Time Frame: Week 3
Week 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

September 19, 2007

First Submitted That Met QC Criteria

September 19, 2007

First Posted (Estimate)

September 20, 2007

Study Record Updates

Last Update Posted (Actual)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQAX576A2202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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