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Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

NCT ID: NCT01266135

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-04-30

Brief Summary

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This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of QAX576 in patients with idiopathic pulmonary fibrosis.

Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis

Keywords

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Interstitial Lung Disease Usual Interstitial Pneumonia Fibrosis, Pulmonary Fibrosis, Respiratory Disease, Interstitial Lung Disease, Biological Therapy, Therapeutic Uses,

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm 1: QAX576 10 mg/kg

Group Type EXPERIMENTAL

QAX576

Intervention Type DRUG

QAX576 10 mg/kg intravenous infusion

Arm 2: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to QAX576 intravenous infusion

Interventions

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QAX576

QAX576 10 mg/kg intravenous infusion

Intervention Type DRUG

Placebo

Placebo to QAX576 intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Idiopathic Pulmonary Fibrosis (IPF), based on an appropriate clinical definition of IPF as detailed in the ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management Diagnosis must be confirmed by a diagnostic HRCT or surgical lung biopsy.
* A 6-minute walk test (6MWT) distance ≥50 meters at Screening (use of supplemental oxygen allowed).

Exclusion Criteria

* Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports tobacco use or has a urine cotinine levels in the range defined as 'smokers' per the local lab.
* Lung residual volume \> 120% predicted at Screening.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Gainesville, Florida, United States

Site Status

Novartis Investigative Site

Orlando, Florida, United States

Site Status

Novartis Investigative Site

Boston, Massachusetts, United States

Site Status

Novartis Investigative Site

Durham, North Carolina, United States

Site Status

Novartis Investigative Site

Pittsburgh, Pennsylvania, United States

Site Status

Novartis Investigative Site

Nashville, Tennessee, United States

Site Status

Novartis Investigative Site

San Antonio, Texas, United States

Site Status

Novartis Investigative Site

Cambridge, , United Kingdom

Site Status

Novartis Investigative Site

Leicester, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Countries

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United States United Kingdom

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=11844

Results for CQAX576A2203 from the Novartis Clinical Trials website

Other Identifiers

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2010-020688-18

Identifier Type: -

Identifier Source: secondary_id

CQAX576A2203

Identifier Type: -

Identifier Source: org_study_id