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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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

Key facts

Study ID

NCT01266135

Run by

Novartis Pharmaceuticals

People needed

40

Starts

2010-12-01

Expected to finish

2013-04-01

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Gainesville, Florida, United States
• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Durham, North Carolina, United States
• Novartis Investigative Site — Pittsburgh, Pennsylvania, United States
• Novartis Investigative Site — Nashville, Tennessee, United States
• Novartis Investigative Site — San Antonio, Texas, United States
• Novartis Investigative Site — Cambridge, United Kingdom
• Novartis Investigative Site — Leicester, United Kingdom
• Novartis Investigative Site — London, United Kingdom

Full record on ClinicalTrials.gov

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