Clinical trial NCT01266135: Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Official title: Randomized, Double-blind, Placebo-controlled, Multiple-dose, Exploratory Proof of Concept Study to Assess the Safety, Tolerability, Efficacy, Pharmacodynamic (PD) and Pharmacokinetics of QAX576 in Patients With Rapidly Progressive IPF
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Interstitial Lung Disease
Usual Interstitial Pneumonia
Fibrosis,
Pulmonary Fibrosis,
Respiratory Disease,
Interstitial Lung Disease,
Biological Therapy,
Therapeutic Uses,
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-12-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the safety, tolerability, and effect on lung function of multiple intravenous doses of QAX576 in patients with IPF
timeFrame: 1 year
measure: Change in forced vital capacity (FVC) at 52 weeks as compared to baseline
timeFrame: 1 year
measure: Safety and tolerability of QAX576.
timeFrame: 1 year
Secondary outcomes:
measure: To evaluate the effect of multiple intravenous doses of QAX576 on measures of clinical efficacy
timeFrame: 1 year
measure: To determine the pharmacokinetics of of QAX576 by measuring concentrations of QAX576 in blood
timeFrame: 1 year
measure: Time to clinical worsening:
timeFrame: 1 year
measure: Exacerbation of IPF
timeFrame: 1 year
measure: Progression of fibrosis
timeFrame: 1 year
measure: Pharmacokinetics of QAX576
timeFrame: 1 year
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Novartis Investigative Site
state: Florida
city: Orlando
country: United States
facility: Novartis Investigative Site
state: Florida
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Durham
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Nashville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: Cambridge
country: United Kingdom
facility: Novartis Investigative Site
city: Leicester
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: