SD, IL-13 Production Rate in IPF | NCT00532233

Studies
SD, IL-13 Production Rate in IPF

NCT00532233

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Dec 19, 2020Actual

Enrollment

52Actual

Phase

Phase 2

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

QAX576

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Sep 19, 2007

First Submission Date that Met QC Criteria

Sep 19, 2007

First Posted Date

Sep 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Aug 20, 2020

Certification/Extension First Submitted that Passed QC Review

Aug 20, 2020

Certification/Extension First Posted Date

Aug 28, 2020Actual

Last Update Submitted Date

Dec 11, 2020

Last Update Posted Date

Dec 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Label	Type	Description	Intervention Names
1	Experimental	QAX576	Drug: QAX576

Name	Type	Description	Arm Group Labels	Other Names
QAX576	Drug		1

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director
Novartis	Investigative site	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Denver	Colorado	80206	United States
Novartis Investigative Site

Label	URL
Clinical Trial Results for CQAX576A2202 at Novartis Clinical Trials.com	View source

Condition Browse Module

MeSH Terms

ID	Term
D054990	Idiopathic Pulmonary Fibrosis

Ancestor Terms

ID	Term
D011658	Pulmonary Fibrosis
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided